Intervertebral Fusion Device With Bone Graft, Lumbar
The lumbar intervertebral fusion device with bone graft is an orthopedic implant intended to stabilize spinal segments and promote bony fusion, thereby restricting motion and decreasing pain in patients with lumbar spinal disorders. It is classified as FDA Class II under 21 CFR 888.3080 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MAX and the device carries an implant flag reflecting its surgical placement between vertebral bodies. Full GMP compliance is required.
Basic Information
- Product Code
- MAX
- Device Class
- FDA class 2
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 870 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | Jul 08, 2025 | Substantially Equivalent | L&K BIOMED Co., Ltd. |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Jul 07, 2025 | Substantially Equivalent | Life Spine, Inc. |
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams | Jul 07, 2025 | Substantially Equivalent | Carlsmed, Inc. |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Jun 30, 2025 | Substantially Equivalent | Carlsmed Inc. |
| K243816 | Testa TP Pivoting Spacer System | Jun 27, 2025 | Substantially Equivalent | Spine Wave, Inc. |
| K251003 | X-PAC® LLIF Expandable Lateral Cage System | Jun 25, 2025 | Substantially Equivalent | Expanding Innovations, Inc |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Jun 16, 2025 | Substantially Equivalent | Expanding Innovations, Inc. |
| K243973 | FIX-L PEEK PLIF and T-PLIF System | Jun 12, 2025 | Substantially Equivalent | Jeil Medical Corporation |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | Jun 02, 2025 | Substantially Equivalent | Acuity Surgical Devices, LLC |
| K243116 | FlareHawk Interbody Fusion System | May 21, 2025 | Substantially Equivalent | Integrity Implants Inc. dba Accelus |
| K250669 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Apr 22, 2025 | Substantially Equivalent | Medtronic Sofamor Danek, USA Inc. |
| K250373 | ProLift Expandable Spacer System | Apr 09, 2025 | Substantially Equivalent | Life Spine, Inc. |
| K250667 | DeGen Medical Patient Specific Implant (PSI) System | Apr 04, 2025 | Substantially Equivalent | DeGen Medical |
| K243074 | Spectrum Spine Lumbar Cage System | Apr 04, 2025 | Substantially Equivalent | Spectrum Spine, Inc. |
| K250186 | GoLIF! Lumbar Interbody Fusion System | Mar 21, 2025 | Substantially Equivalent | GetSet Surgical, SA |
| K242771 | Tesera-k PL System and Tesera-k XL System | Mar 20, 2025 | Substantially Equivalent | Kyocera Medical Technologies, Inc. |
| K241783 | FortiVy OsteoVy Lumbar IBF | Mar 18, 2025 | Substantially Equivalent | Vy Spine, LLC |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | Feb 03, 2025 | Substantially Equivalent | Alphatec Spine |
| K243739 | AxCess® Expandable Interbody System | Jan 24, 2025 | Substantially Equivalent | Elliquence LLC |
| K243668 | ProLift Pivot Expandable Spacer System | Jan 23, 2025 | Substantially Equivalent | Life Spine, Inc. |
| K243670 | Idys® LIF | Dec 31, 2024 | Substantially Equivalent | CLARIANCE |
| K241073 | DZ-Tabone Intervertebral Body Fusion Device | Dec 06, 2024 | Substantially Equivalent | Shenzhen Dazhou Medical Technology Co., Ltd. |
| K242829 | BluEX Lumbar Expandable Cage System | Oct 23, 2024 | Substantially Equivalent | L&K BIOMED Co., Ltd. |
| K242589 | Scarlet® AL-T | Oct 23, 2024 | Substantially Equivalent | Spineart SA |
| K233947 | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System | Oct 10, 2024 | Substantially Equivalent | CTL Medical Corporation |
| K242826 | ProLift Wedge Expandable Spacer System | Oct 08, 2024 | Substantially Equivalent | Life Spine, Inc. |
| K242267 | Gemini Medical Cage System | Oct 08, 2024 | Substantially Equivalent | ZheJiang Decans Medical Devices Co., Ltd. |
| K242457 | EARP Interbody System | Oct 07, 2024 | Substantially Equivalent | Retropsoas Technologies, LLC |
| K242364 | IdentiTi II Interbody System | Oct 04, 2024 | Substantially Equivalent | Alphatec Spine, Inc. |
| K240889 | ARTFX Lumbar PEEK Cages | Oct 02, 2024 | Substantially Equivalent | ARTFX Medical |
| K233807 | LumiVy Lumbar IBF System | Sep 24, 2024 | Substantially Equivalent | Vy Spine, LLC |
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Sep 20, 2024 | Substantially Equivalent | Alphatec Spine, Inc. |
| K241332 | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device | Sep 20, 2024 | Substantially Equivalent | Carlsmed, Inc. |
| K242509 | HAnano InterFuse(R) Modular Interbody | Sep 19, 2024 | Substantially Equivalent | Next OrthoSurgical |
| K240250 | 3D Printed PEEK Interbody System | Sep 17, 2024 | Substantially Equivalent | Nvision Biomedical Technologies, Inc. |
| K241438 | Signus Tetris St; Signus Tetris R St | Sep 11, 2024 | Substantially Equivalent | SIGNUS Medizintechnik GmbH |
| K241164 | IB3D PL Spinal System | Sep 06, 2024 | Substantially Equivalent | Medicrea International S.A.S. (Medtronic) |
| K234035 | COSINE Spacer | Sep 06, 2024 | Substantially Equivalent | Globus Medical, Inc. |
| K232996 | Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) | Sep 06, 2024 | Substantially Equivalent | Shanghai Iatrical-Ti Technologies Co Ltd. |
| K241605 | Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology | Sep 05, 2024 | Substantially Equivalent | Nanovis LLC |
| K241328 | aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) | Aug 12, 2024 | Substantially Equivalent | Carlsmed, Inc |
| K240326 | Solar Lumbar Interbody Fusion System | Jul 29, 2024 | Substantially Equivalent | DeGen Medical, Inc. |
| K241413 | sagAlign Lumbar Cage System (Various PNs) | Jul 17, 2024 | Substantially Equivalent | Acuity Surgical Devices, LLC |
| K234077 | SPIRA® Anterior Lumbar Spacers | Jul 12, 2024 | Substantially Equivalent | Camber Spine Technologies |
| K241019 | aprevo® TLIF-C Articulating System | Jul 09, 2024 | Substantially Equivalent | Carlsmed |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System | Jun 20, 2024 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System | Jun 20, 2024 | Substantially Equivalent | Orthofix Medical Inc. |
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | May 28, 2024 | Substantially Equivalent | Orthofix, Inc. |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | Apr 26, 2024 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | Apr 10, 2024 | Substantially Equivalent | Zavation Medical Products LLC |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) | Apr 05, 2024 | Substantially Equivalent | icotec AG |
| K234150 | Lucent® XP | Mar 27, 2024 | Substantially Equivalent | Spinal Elements |
| K232282 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | Mar 22, 2024 | Substantially Equivalent | Carlsmed, Inc. |
| K233375 | Tranquil-L Interbody System | Mar 20, 2024 | Substantially Equivalent | Nexus Spine, LLC |
| K233075 | BioGend Interbody Fusion System 001 Cage | Mar 06, 2024 | Substantially Equivalent | BioGend Therapeutics Co. Ltd. |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion System | Jan 22, 2024 | Substantially Equivalent | restor3d |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System | Jan 18, 2024 | Substantially Equivalent | Curiteva, Inc. |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | Jan 12, 2024 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K230872 | Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System | Dec 12, 2023 | Substantially Equivalent | Shanghai Sanyou Medical Co, LTD |
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System | Dec 08, 2023 | Substantially Equivalent | CoreLink, LLC |
| K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System | Nov 30, 2023 | Substantially Equivalent | Life Spine, Inc. |
| K232069 | Expandable Lumbar Fusion Cage (Type I,Type II) | Nov 29, 2023 | Substantially Equivalent | Shanghai REACH Medical Instrument Co., Ltd. |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Nov 07, 2023 | Substantially Equivalent | GBS Commonwealth Co., Ltd. |
| K232504 | Calibrate CCX Interbody System | Oct 13, 2023 | Substantially Equivalent | Alphatec Spine, Inc. |
| K232014 | CONDUIT ATP Inserters | Sep 01, 2023 | Substantially Equivalent | Enztec Limited |
| K231680 | AccelFix Lumbar Expandable Cage System | Aug 24, 2023 | Substantially Equivalent | L&K BioMed Co., Ltd. |
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Aug 03, 2023 | Substantially Equivalent | Globus Medical Inc. |
| K231275 | Exceed Biplanar Expandable Interbody System | Jul 25, 2023 | Substantially Equivalent | Spine Wave, Inc. |
| K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Jul 13, 2023 | Substantially Equivalent | Alphatec Spine, Inc. |
| K231241 | NanoHive Medical Lumbar Interbody System | Jul 12, 2023 | Substantially Equivalent | NanoHive Medical LLC |
| K230942 | SPIRA® Posterior Lumbar Spacers | Jul 11, 2023 | Substantially Equivalent | Camber Spine Technologies |
| K231252 | Ventana L Spinal System | Jun 30, 2023 | Substantially Equivalent | Spinal Elements, Inc. |
| K231199 | Solar Lumbar Interbody Fusion System | Jun 16, 2023 | Substantially Equivalent | DeGen Medical |
| K231359 | RODIN Expandable Lumbar Cage System | Jun 09, 2023 | Substantially Equivalent | CTL Medical Corporation |
| K230851 | Kodiak Lumbar Spacer System | May 26, 2023 | Substantially Equivalent | Met One Technologies, LLC |
| K231140 | aprevo® transforaminal lumbar interbody fusion device | May 19, 2023 | Substantially Equivalent | Carlsmed, Inc. |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion Systems | May 16, 2023 | Substantially Equivalent | Eminent Spine, LLC |
| K223335 | SIRION Lateral Lumbar Interbody System | May 09, 2023 | Substantially Equivalent | Astura Medical |
| K223430 | ProLift Micro Expandable Spacer System | May 04, 2023 | Substantially Equivalent | Life Spine, Inc. |
| K223868 | PYXIS 3D Titanium Cage System | Apr 26, 2023 | Substantially Equivalent | GS Medical Co. Ltd. |
| K223611 | Calibrate LTX Interbody System | Mar 29, 2023 | Substantially Equivalent | Alphatec Spine, Inc. |
| K223418 | DeGen Impulse AM System | Mar 17, 2023 | Substantially Equivalent | DeGen Medical |
| K223688 | CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments | Mar 08, 2023 | Substantially Equivalent | Medos International SÀRL |
| K223776 | PEEK Spinal Infusion Cage | Mar 03, 2023 | Substantially Equivalent | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd |
| K223174 | X-Pac Expandable LLIF Cage System | Feb 14, 2023 | Substantially Equivalent | Expanding Innovations, Inc. |
| K223474 | PathLoc-TA Expandable Lumbar Cage System | Jan 13, 2023 | Substantially Equivalent | L&K Biomed Co., Ltd. |
| K223412 | LumiVy Lumbar IBF System | Jan 06, 2023 | Substantially Equivalent | Vy Spine, LLC |
| K223671 | CONDUIT LLIF Straight Inserters | Jan 05, 2023 | Substantially Equivalent | Enztec Limited |
| K223654 | Medussa-PL Cage | Dec 28, 2022 | Substantially Equivalent | Medyssey USA, Inc. |
| K213653 | 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM | Dec 19, 2022 | Substantially Equivalent | Solco Biomedical Company India Private Limited |
| K223251 | Hexanium PLIF | Dec 16, 2022 | Substantially Equivalent | SpineVision, S.A.S. |
| K223153 | Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology | Dec 16, 2022 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. |
| K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | Dec 08, 2022 | Substantially Equivalent | Southern Medical (Pty) Ltd |
| K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Dec 05, 2022 | Substantially Equivalent | Life Spine Inc. |
| K222455 | Calibrate LTX Interbody System | Nov 18, 2022 | Substantially Equivalent | Alphatec Spine, Inc. |
| K222732 | WaveForm A Interbody System | Nov 07, 2022 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K221719 | ABTross ALIF Expandable Cage System | Nov 03, 2022 | Substantially Equivalent | Aegis Spine, Inc. |
| K223065 | Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices | Oct 26, 2022 | Substantially Equivalent | Adcura, Inc. |
| K222203 | DualXSLIM(R) T/PLIF | Oct 18, 2022 | Substantially Equivalent | Amplify Surgical, Inc. |
| K222797 | X-Pac Expandable Lumbar Cage System | Oct 14, 2022 | Substantially Equivalent | Expanding Innovations, inc |
| K221858 | ZSFab Lumbar Interbody System | Oct 14, 2022 | Substantially Equivalent | ZS Fab Inc. |
| K221172 | FOCUS Interbody System | Oct 14, 2022 | Substantially Equivalent | OC Medical Devices |
| K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System | Oct 07, 2022 | Substantially Equivalent | Alphatec Spine |
| K213417 | Ghost Spacer System | Sep 29, 2022 | Substantially Equivalent | Life Spine, Inc. |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation Plate | Sep 15, 2022 | Substantially Equivalent | CTL Medical Corporation |
| K220953 | ChoiceSpine TigerShark M, Modular Interbody System | Sep 13, 2022 | Substantially Equivalent | ChoiceSpine, LLC |
| K221325 | CONDUIT Lateral Switch Plate | Aug 25, 2022 | Substantially Equivalent | Medos International, SARL |
| K221844 | TDM Lumbar Interbody Fusion Cage System | Aug 17, 2022 | Substantially Equivalent | TDM Co., Ltd |
| K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices | Aug 12, 2022 | Substantially Equivalent | Carlsmed, Inc. |
| K221687 | Pegasus-X Expandable PLIF System | Jul 27, 2022 | Substantially Equivalent | GS Medical Co. Ltd. |
| K221535 | Align Lumbar Interbody Fusion System | Jul 22, 2022 | Substantially Equivalent | Acuity Surgical Devices, LLC |
| K220449 | DePuy CONDUIT LLIF SQUID Inserter | Jun 28, 2022 | Substantially Equivalent | Enztec Limited |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | Jun 21, 2022 | Substantially Equivalent | NuVasive, Incorporated |
| K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | Jun 17, 2022 | Substantially Equivalent | Restor3d |
| K220782 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System | Jun 09, 2022 | Substantially Equivalent | Alphatec Spine, Inc. |
| K220581 | Zavation eZspand Interbody System | Jun 02, 2022 | Substantially Equivalent | Zavation Medical Products, LLC |
| K220902 | Navagio Lumbar Cage | May 27, 2022 | Substantially Equivalent | Kalitec Medical, LLC |
| K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | May 10, 2022 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | May 04, 2022 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K212477 | EARP Interbody System | Apr 28, 2022 | Substantially Equivalent | Nvision Biomedical Technologies, Inc. |
| K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Apr 12, 2022 | Substantially Equivalent | Medtronic Sofamor Danek USA |
| K212811 | Ti3Z Lumbar Interbody System | Apr 12, 2022 | Substantially Equivalent | Zavation Medical Products, LLC |
| K213355 | Toro-L Interbody Fusion System | Mar 25, 2022 | Substantially Equivalent | Integrity Implants Inc. |
| K220655 | X-Pac Expandable Lumbar Cage System | Mar 24, 2022 | Substantially Equivalent | Expanding Innovations, Inc |
| K220453 | FlareHawk Interbody Fusion System | Mar 24, 2022 | Substantially Equivalent | Integrity Implants Inc. |
| K220096 | Genesys Spine 3DP Lumbar Interbody System | Mar 09, 2022 | Substantially Equivalent | Genesys Spine |
| K213441 | PathLoc Lumbar Interbody Fusion Cage System | Mar 09, 2022 | Substantially Equivalent | L&K BioMed Co., Ltd. |
| K212930 | LumiVy Lumbar IBF System | Feb 16, 2022 | Substantially Equivalent | Vy Spine, LLC |
| K213951 | FORZA XP Expandable Spacer System | Jan 05, 2022 | Substantially Equivalent | Orthofix US LLC |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty | Dec 23, 2021 | Substantially Equivalent | NuVasive, Incorporated |
| K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Dec 08, 2021 | Substantially Equivalent | Medtronic Sofamor Danek USA, INC. |
| K212075 | ShurFit Lumbar Interbody System | Dec 08, 2021 | Substantially Equivalent | Precision Spine, Inc. |
| K212050 | NGM WAVE PLIF Cage | Dec 01, 2021 | Substantially Equivalent | NGMedical GmbH |
| K212653 | Catalyft LS Expandable Interbody System | Nov 19, 2021 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. |
| K211845 | Deploy Expandable Interbody System | Nov 16, 2021 | Substantially Equivalent | Southern Spine LLC |
| K212823 | DePuy CONDUIT LLIF Angled Inserters | Nov 01, 2021 | Substantially Equivalent | Enztec Limited |
| K212831 | MectaLIF Extension | Oct 29, 2021 | Substantially Equivalent | Medacta International S .A. |
| K212389 | Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF | Oct 29, 2021 | Substantially Equivalent | Intelivation LLC |
| K212520 | ProLift Micro Expandable Spacer System | Oct 08, 2021 | Substantially Equivalent | Life Spine, Inc. |
| K211740 | DualX | Sep 29, 2021 | Substantially Equivalent | Amplify Surgical, Inc. |
| K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System | Sep 22, 2021 | Substantially Equivalent | Alphatec Spine, Inc. |
| K211689 | KEYSTONE PEEK Cage System | Sep 21, 2021 | Substantially Equivalent | Shanghai Sanyou Medical Co, LTD |
| K211474 | Kleiner KG2 System | Sep 14, 2021 | Substantially Equivalent | Baat Medical Products BV |
| K212540 | Explorer TO System | Sep 10, 2021 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K203014 | EndoLIF Delta-Cage and DoubleWedge-Cage | Sep 01, 2021 | Substantially Equivalent | joimax GmbH |
| K212070 | KMTI S141 Lumbar Interbody Fusion System | Aug 30, 2021 | Substantially Equivalent | Kyocera Medical Technologies, Inc. |
| K210090 | Impulse AM Interbody Fusion System | Aug 30, 2021 | Substantially Equivalent | DeGen Medical |
| K211413 | BEE PLIF Cage | Aug 27, 2021 | Substantially Equivalent | NGMedical GmbH |
| K210800 | IO Expandable Lumbar Interbody Fusion System | Aug 20, 2021 | Substantially Equivalent | MiRus, LLC |
| K211873 | PSX Interbody System | Aug 10, 2021 | Substantially Equivalent | Alphatec Spine, Inc. |
| K211388 | Lateral Spine Truss System (LSTS) Interbody Fusion Device | Aug 05, 2021 | Substantially Equivalent | 4WEB Medical, Inc. |
| K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene, SeaSpine Vu ePOD System, SeaSpine Vu aPOD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System | Jul 07, 2021 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K203003 | Pantheon IBFD | Jul 07, 2021 | Substantially Equivalent | Pantheon Spinal |
| K210542 | aprevo Transforaminal IBF | Jun 30, 2021 | Substantially Equivalent | Carlsmed, Inc. |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System | Jun 30, 2021 | Substantially Equivalent | Spinal Elements, Inc. |
| K211306 | LABYRINTH | Jun 24, 2021 | Substantially Equivalent | Zavation Medical Products LLC |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | Jun 15, 2021 | Substantially Equivalent | Camber Spine Technologies, LLC |
| K203802 | X-Pac Expandable Lumbar Cage System | Jun 07, 2021 | Substantially Equivalent | Expanding Innovations, Inc |
| K210583 | SeaSpine WaveForm A Interbody System | Jun 02, 2021 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System | May 26, 2021 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. |
| K210425 | Catalyft PL Expandable Interbody System | May 24, 2021 | Substantially Equivalent | Medtronic Sofamor Danek, USA Inc. |
| K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System | May 24, 2021 | Substantially Equivalent | NuVasive, Incorporated |
| K210439 | NuVasive MOD-EX XLIF Interbody System | May 12, 2021 | Substantially Equivalent | NuVasive, Incorporated |
| K210728 | CONDUIT Instruments | May 06, 2021 | Substantially Equivalent | Medos International, SARL |
| K210061 | ProLift Lateral HELO Fixated | Apr 30, 2021 | Substantially Equivalent | Life Spine, Inc. |
| K201024 | Expandable Titanium PLIF/TLIF System | Apr 29, 2021 | Substantially Equivalent | Spectrum Spine, LLC |
| K200919 | Idys ALIF 3DTi | Apr 12, 2021 | Substantially Equivalent | CLARIANCE |
| K203254 | Lucent 3D Spinal System | Mar 26, 2021 | Substantially Equivalent | Spinal Elements, Inc. |
| K203038 | Toro-L Interbody Fusion System | Mar 26, 2021 | Substantially Equivalent | Integrity Implants Inc |
| K203361 | ProLift Wedge Expandable Spacer System | Mar 17, 2021 | Substantially Equivalent | Life Spine, Inc. |
| K210359 | Hexanium TLIF | Mar 10, 2021 | Substantially Equivalent | SpineVision SAS |
| K203576 | FORZA Ti Spacer System | Mar 03, 2021 | Substantially Equivalent | Orthofix Inc. |
| K210155 | Duo Expandable Interbody Fusion System | Feb 19, 2021 | Substantially Equivalent | Spineology Inc. |
| K202380 | Born PT-LIF Cage HA | Feb 19, 2021 | Substantially Equivalent | SpineworxX AG |
| K200551 | MectaLIF Transforaminal TiPEEK | Feb 12, 2021 | Substantially Equivalent | Medacta Inernational SA |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers | Feb 02, 2021 | Substantially Equivalent | Globus Medical Inc. |
| K203531 | XYPAN Expandable Lumbar Cage System | Jan 29, 2021 | Substantially Equivalent | Aegis Spine, Inc. |
| K203327 | VERTACONNECT TLIF Cage | Jan 25, 2021 | Substantially Equivalent | SIGNUS Medizintechnik |
| K203683 | CarboClear Lumbar Cage System | Jan 15, 2021 | Substantially Equivalent | CarboFix Orthpedics Ltd. |
| K203308 | Ali Interbody Fusion System | Jan 15, 2021 | Substantially Equivalent | Raed M. Ali, M.D., Inc. |
| K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System | Jan 12, 2021 | Substantially Equivalent | NuVasive, Incorporated |
| K202495 | SIRION Lateral Lumbar Interbody Fusion | Jan 06, 2021 | Substantially Equivalent | Astura Medical, LLC |
| K202820 | Australis Anterior Lumbar Cage System | Dec 22, 2020 | Substantially Equivalent | Prism Surgical Designs Pty Ltd |
| K202298 | Lucent XP, Lucent XP Curved | Dec 22, 2020 | Substantially Equivalent | Spinal Elements, Inc. |
| K201287 | Impulse Interbody Fusion System | Dec 22, 2020 | Substantially Equivalent | DeGen Medical |
| K201755 | WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System | Dec 15, 2020 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K202034 | aprevo Intervertebral Body Fusion Device | Dec 03, 2020 | Substantially Equivalent | Carlsmed, Inc. |
| K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene; SeaSpine Vu ePOD System; and SeaSpine Reef TH System, SeaSpine Vu aPOD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System | Nov 25, 2020 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K202587 | ATEC Lateral Interbody System | Nov 06, 2020 | Substantially Equivalent | Alphatec Spine, Inc. |
| K202198 | FlareHawk Interbody Fusion System | Nov 03, 2020 | Substantially Equivalent | Integrity Implants Inc. |
| K200316 | UNiD IB3D ALIF | Oct 30, 2020 | Substantially Equivalent | Medicrea International S.A. |
| K201692 | NuVasive Modulus XLIF Interbody System | Oct 29, 2020 | Substantially Equivalent | NuVasive, Incorporated |
| K200084 | Zavation IBF System | Oct 19, 2020 | Substantially Equivalent | Zavation Medical Products LLC |
| K202305 | Zavation IBF System | Oct 13, 2020 | Substantially Equivalent | Zavation Medical Products, LLC |
| K201939 | GAIA Lumbar Interbody Fusion Device (LIFD) Family | Oct 08, 2020 | Substantially Equivalent | PrinterPrezz |
| K201453 | Fortilink Cages with TiPlus Technology | Oct 07, 2020 | Substantially Equivalent | Paradigm Spine, GmbH |
| K200953 | NuVasive® Cohere® Thoracolumbar Interbody System | Oct 06, 2020 | Substantially Equivalent | NuVasive, Incorporated |
| K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System | Sep 25, 2020 | Substantially Equivalent | NuVasive, Incorporated |
| K201367 | FlareHawk TiHawk9 Interbody Fusion System | Sep 23, 2020 | Substantially Equivalent | Integrity Implants Inc. |
| K201145 | X-Pac Expandable Lumbar Cage System | Sep 10, 2020 | Substantially Equivalent | Expanding Innovations, Inc. |
| K201721 | TruLift Expandable Spacer System | Sep 04, 2020 | Substantially Equivalent | Life Spine Inc. |
| K200958 | MODULIF-A Anterior Lumbar Interbody Fusion System | Aug 28, 2020 | Substantially Equivalent | Spinal Stability, LLC |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Aug 26, 2020 | Substantially Equivalent | Medtronic Sofamor Danek |
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | Aug 26, 2020 | Substantially Equivalent | CTL Medical Corporation |
| K201500 | Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer | Aug 04, 2020 | Substantially Equivalent | Life Spine Inc. |
| K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Jul 15, 2020 | Substantially Equivalent | Innovasis, Inc. |
| K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage | Jul 15, 2020 | Substantially Equivalent | EIT Emerging Implant Technologies GmbH |
| K193172 | Luna XD Ti Interbody Fusion System | Jul 02, 2020 | Substantially Equivalent | Benvenue Medical, Inc. |
| K193106 | SpineFrontier Lumbar Interbody Fusion Device System | Jun 19, 2020 | Substantially Equivalent | SpineFrontier, Inc. |
| K200283 | Medussa-PL Cage | Jun 18, 2020 | Substantially Equivalent | Medyssey USA, Inc. |
| K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | Jun 10, 2020 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K200920 | Idys ALIF ZP 3DTi | May 29, 2020 | Substantially Equivalent | Clariance, SAS |
| K200969 | NEXXT MATRIXX System | May 21, 2020 | Substantially Equivalent | Nexxt Spine LLC |
| K191906 | MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF | May 18, 2020 | Substantially Equivalent | MiRus, LLC |
| K200991 | EVOL Spinal Interbody System | May 13, 2020 | Substantially Equivalent | Cutting Edge Spine, LLC |
| K193457 | AUDERE Lumbar Spacer System | May 12, 2020 | Substantially Equivalent | Met One Technologies |
| K200816 | SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | Apr 30, 2020 | Substantially Equivalent | SpineEX, Inc. |
| K193636 | SeaSpine Reef TH System | Apr 24, 2020 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K200613 | Tritanium® X TL Expandable Curved Posterior Lumbar Cage | Apr 15, 2020 | Substantially Equivalent | Stryker Corporation |
| K191353 | COMET Lumbar Interbody Fusion Cage | Apr 14, 2020 | Substantially Equivalent | BAUI Biotech Co., Ltd. |
| K200552 | EVOS Lumbar Interbody System | Apr 02, 2020 | Substantially Equivalent | Cutting Edge Spine, LLC |
| K192006 | SIRION Lateral Lumbar Interbody System | Apr 02, 2020 | Substantially Equivalent | Astura Medical, LLC |
| K193541 | NuVasive Cohere Thoracolumbar Interbody System | Mar 30, 2020 | Substantially Equivalent | NuVasive, Incorporated |
| K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Mar 23, 2020 | Substantially Equivalent | Medtronic Sofamor Danek, USA Inc. |
| K193418 | SeaSpine Skipjack System | Mar 13, 2020 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K200048 | MectaLIF Anterior Simple | Mar 09, 2020 | Substantially Equivalent | Medacta International SA |
| K193378 | CarboClear Lumbar Cage System | Mar 02, 2020 | Substantially Equivalent | CarboFix Orthopedics Ltd. |
| K190363 | Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage | Feb 21, 2020 | Substantially Equivalent | Omnia Medical, LLC |
| K193255 | Largo PEEK Interbody System | Feb 20, 2020 | Substantially Equivalent | FloSpine, LLC |
| K193203 | MOJAVE Expandable Interbody System | Feb 18, 2020 | Substantially Equivalent | K2M, Inc. |
| K193521 | Steerable Plateau Ti | Feb 06, 2020 | Substantially Equivalent | Life Spine, Inc. |
| K193258 | ProLift Expandable System | Jan 31, 2020 | Substantially Equivalent | Life Spine Inc. |
| K192502 | Anatomic PEEK Cervical Fusion System, Anatomic PEEK PTC Cervical Fusion System, Capstone Spinal System, Capstone PTC Spinal System, Capstone Control Spinal System, Capstone Control PTC Spinal System, Clydesdale Spinal System, Clydesdale PTC Spinal System, Cornerstone PSR Cervical Fusion System, Crescent Spinal System, Crescent Spinal System Titanium, Divergence Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L Anterior/Oblique Lumbar Fus | Jan 22, 2020 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc |
| K193370 | Nexxt Matrixx System | Jan 21, 2020 | Substantially Equivalent | Nexxt Spine LLC |
| K192115 | SABLE Expandable Spacer | Jan 14, 2020 | Substantially Equivalent | Globus Medical Inc. |
| K193645 | nva, nvp, and nvt | Jan 13, 2020 | Substantially Equivalent | Nvision Biomedical Technologies, Inc. |
| K192687 | TrellOss-L MPF | Jan 09, 2020 | Substantially Equivalent | Nexxt Spine LLC |
| K192497 | EVOL ha - D Lateral Interbody Fusion System | Jan 06, 2020 | Substantially Equivalent | Cutting Edge Spine, LLC |
| K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | Dec 20, 2019 | Substantially Equivalent | Pioneer Surgical Technology, Inc., DBA RTI Surgical, Inc. |
| K193174 | Keos Lumbar IBFD | Dec 16, 2019 | Substantially Equivalent | Keos |
| K181548 | Pantheon Spinal Pontus Interbody Fusion Device | Dec 16, 2019 | Substantially Equivalent | Pantheon Spinal |
| K191796 | Neo Cage System | Dec 13, 2019 | Substantially Equivalent | Neo Medical S.A. |
| K182987 | Genesys Spine 3DP Lumbar Interbody System | Dec 12, 2019 | Substantially Equivalent | Genesys Spine |
| K192132 | SeaSpine Beachside System | Dec 03, 2019 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K192026 | Peridot Intervertebral body fusion System | Nov 26, 2019 | Substantially Equivalent | GBS Commonwealth Co., Ltd. |
| K192248 | Cortina [MAX] Lumbar Cage System | Nov 25, 2019 | Substantially Equivalent | NeuroStructures, Inc. |
| K190721 | LongBow Ti | Nov 14, 2019 | Substantially Equivalent | Life Spine Inc. |
| K190544 | XIHPOS ZFUZE Interbody Fusion System | Nov 01, 2019 | Substantially Equivalent | DiFusion Technologies |
| K191134 | IB3D ALIF | Oct 30, 2019 | Substantially Equivalent | Medicrea International S.A. |
| K180347 | 3d Cage | Oct 28, 2019 | Substantially Equivalent | Fims Co., Ltd. |
| K192760 | NuVasive Modulus XLIF Interbody System | Oct 18, 2019 | Substantially Equivalent | NuVasive, Incorporated |
| K192434 | DualX Lumbar Intervertebral Body Fusion Device | Oct 15, 2019 | Substantially Equivalent | Amplify Surgical Inc |
| K191791 | TranS1 Interbody Fusion System | Sep 25, 2019 | Substantially Equivalent | TranS1 |
| K190483 | SPIRA Open Matrix ALIF and LLIF | Sep 23, 2019 | Substantially Equivalent | Camber Spine Technologies |
| K191391 | HEDRON Lumbar Spacers | Sep 18, 2019 | Substantially Equivalent | Globus Medical Inc. |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage | Sep 18, 2019 | Substantially Equivalent | Solco Biomedical Co., Ltd. |
| K190708 | AccelFix Lumbar Interbody Fusion Cage System | Sep 16, 2019 | Substantially Equivalent | L&K Biomed Co., Ltd. |
| K191516 | Ali Interbody Fusion System | Sep 12, 2019 | Substantially Equivalent | Raed M. Ali, MD., Inc. |
| K190398 | Republic Spine Restore Intervertebral Body Fusion System | Sep 12, 2019 | Substantially Equivalent | Republic Spine LLC |
| K183407 | Triton Cage | Aug 30, 2019 | Substantially Equivalent | Medyssey USA, Inc. |
| K191339 | Zavation eZspand Interbody System | Aug 19, 2019 | Substantially Equivalent | Zavation Medical Products, LLC |
| K191311 | ATEC Lateral Interbody System | Aug 12, 2019 | Substantially Equivalent | Alphatec Spine, Inc. |
| K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage | Jul 25, 2019 | Substantially Equivalent | STRYKER SPINE |
| K190488 | ProLift Expandable System | Jul 23, 2019 | Substantially Equivalent | Life Spine Inc. |
| K190680 | FAVO S-TLIF | Jul 18, 2019 | Substantially Equivalent | Silony Medical GmbH |
| K182158 | UNiD Patient-matched PLIF cage | Jul 15, 2019 | Substantially Equivalent | MEDICREA INTERNATIONAL S.A. |
| K191408 | Nexxt Matrixx System | Jul 10, 2019 | Substantially Equivalent | Nexxt Spine LLC |
| K183243 | Velofix TLIF Cage | Jul 10, 2019 | Substantially Equivalent | U&i Corporation |
| K191367 | Harrier-SA Lumbar Interbody System | Jul 05, 2019 | Substantially Equivalent | ChoiceSpine LLC |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System | Jul 05, 2019 | Substantially Equivalent | Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. |
| K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | Jul 03, 2019 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc |
| K183064 | TxTi IBF System | Jun 28, 2019 | Substantially Equivalent | Innovasis, Inc. |
| K190684 | LxHA PEEK Lateral IBF System | Jun 17, 2019 | Substantially Equivalent | Innovasis, Inc. |
| K191005 | ProLift® Expandable System | Jun 13, 2019 | Substantially Equivalent | Life Spine Inc. |
| K183560 | Luna 3D GEN2 Interbody Fusion System | May 23, 2019 | Substantially Equivalent | Benvenue Medical, Inc. |
| K190092 | UNiD Patient specific 3D printed TLIF cage | May 08, 2019 | Substantially Equivalent | Medicrea International S.A. |
| K190165 | Capstone Control Spinal System | May 06, 2019 | Substantially Equivalent | Medtronic Sofamor Danek USA, INC. |
| K182877 | HALF DOME Posterior Lumbar Interbody System | May 03, 2019 | Substantially Equivalent | Astura Medical, LLC |
| K190364 | CancelleX Porous Titanium Lumbar Interbody Device | Apr 18, 2019 | Substantially Equivalent | Xenco Medical, LLC |
| K183184 | FlareHawk Interbody Fusion System | Apr 03, 2019 | Substantially Equivalent | Integrity Implants Inc |
| K182349 | CONCORDE LIFT | Apr 03, 2019 | Substantially Equivalent | Medos International, SARL |
| K182920 | MiRus Lumbar Interbody Fusion System consisting of CALLISTO PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES PEEK Anterior Lumbar Interbody Fusion (ALIF) | Mar 13, 2019 | Substantially Equivalent | MiRus, LLC |
| K183092 | Kuros TLIF Cage | Mar 08, 2019 | Substantially Equivalent | Kuros Biosciences BV |
| K190055 | Duo Lumbar Interbody Fusion Device | Mar 07, 2019 | Substantially Equivalent | Spineology Inc. |
| K173518 | Spectrum Spine Expandable Cages (SSEC) | Mar 07, 2019 | Substantially Equivalent | Spectrum Spine, LLC |
| K190193 | SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices | Mar 04, 2019 | Substantially Equivalent | SpineEX Inc. |
| K183705 | IdentiTi Porous Ti Interbody System | Mar 01, 2019 | Substantially Equivalent | Alphatec Spine, Inc. |
| K183259 | Idys TLIF TiVac | Mar 01, 2019 | Substantially Equivalent | Clariance SAS |
| K182406 | Altus Spine Interbody Fusion System | Feb 22, 2019 | Substantially Equivalent | Altus Partners, LLC |
| K183049 | Reliance Lumbar IBF System | Feb 15, 2019 | Substantially Equivalent | Reliance Medical Systems LLC |
| K183659 | Omnia Medical Rotary PLIF System | Feb 06, 2019 | Substantially Equivalent | Omnia Medical, LLC |
| K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | Feb 04, 2019 | Substantially Equivalent | EIT Emerging Implant Technologies GmbH |
| K181048 | Neo Cage System TM | Jan 29, 2019 | Substantially Equivalent | Neo Medical S.A. |
| K180822 | VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System | Jan 28, 2019 | Substantially Equivalent | Wenzel Spine, Inc. |
| K180230 | NEST Interbody System | Jan 25, 2019 | Substantially Equivalent | Paonan Biotech Co., Ltd. |
| K180228 | II-Type Intervertebral Spacer | Jan 11, 2019 | Substantially Equivalent | Paonan Biotech Co., Ltd. |
| K182210 | TiWAVE-L Porous Titanium Lumbar Cage | Jan 07, 2019 | Substantially Equivalent | Kalitec Medical, LLC |
| K182114 | FlareHawk Interbody Fusion System | Jan 07, 2019 | Substantially Equivalent | Integrity Implants Inc |
| K181589 | Curiteva Lumbar Interbody Fusion System | Dec 20, 2018 | Substantially Equivalent | Curiteva, LLC |
| K183239 | CoreLink F3D Lateral System | Dec 19, 2018 | Substantially Equivalent | Corelink, LLC |
| K181899 | ROCCIA® PLIF | Dec 13, 2018 | Substantially Equivalent | Silony Medical GmbH |
| K181625 | Life Spine Resolute Threaded Cage System | Dec 11, 2018 | Substantially Equivalent | Life Spine Inc. |
| K182584 | Lucent® XP | Dec 10, 2018 | Substantially Equivalent | Spinal Elements Inc |
| K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Dec 06, 2018 | Substantially Equivalent | Globus Medical Inc. |
| K181231 | DePuy Synthes T-PAL Spacer System | Dec 06, 2018 | Substantially Equivalent | DePuy Synthes Spine |
| K181970 | MectaLIF Posterior Extension | Dec 04, 2018 | Substantially Equivalent | Medacta International SA |
| K182746 | ATEC ALIF and LLIF Spacer System | Nov 27, 2018 | Substantially Equivalent | Alphatec Spine, Inc. |
| K182470 | Plateau Spacer System | Nov 26, 2018 | Substantially Equivalent | Life Spine |
| K181963 | ostaPek Interbody Fusion Cages | Nov 14, 2018 | Substantially Equivalent | coLigne, AG |
| K181829 | Velofix TLIF Cage | Nov 14, 2018 | Substantially Equivalent | U&I Corporation |
| K181837 | Spinal Elements Ti-Bond coated devices | Nov 02, 2018 | Substantially Equivalent | Spinal Elements Inc. |
| K182322 | Duo Lumbar Interbody Fusion Device | Oct 24, 2018 | Substantially Equivalent | Spineology Inc |
| K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Oct 12, 2018 | Substantially Equivalent | EIT Emerging Implant Technologies GmbH |
| K181860 | NuVasive Cohere Thoracolumbar Interbody System | Oct 05, 2018 | Substantially Equivalent | NuVasive, Incorporated |
| K181531 | SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | Oct 05, 2018 | Substantially Equivalent | SpineEX Inc. |
| K181397 | DualX | Sep 27, 2018 | Substantially Equivalent | Innovasive, Inc. |
| K181591 | Fixated Asfora BULLET CAGE® (FABC) | Sep 26, 2018 | Substantially Equivalent | Medical Designs, LLC |
| K181702 | Tranquil-L Interbody System | Sep 21, 2018 | Substantially Equivalent | Nexus Spine, LLC |
| K181337 | Sypher Spacer System | Sep 18, 2018 | Substantially Equivalent | Biogennix, LLC |
| K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System | Sep 11, 2018 | Substantially Equivalent | Renovis Surgical Technologies |
| K181380 | LnK Lumbar Interbody Fusion Cage System | Sep 11, 2018 | Substantially Equivalent | L&K BIOMED Co., Ltd. |
| K181483 | Tranquil Interbody System | Aug 27, 2018 | Substantially Equivalent | Nexus Spine, LLC |
| K180373 | CancelleX Porous Titanium Lumbar Interbody Device | Aug 24, 2018 | Substantially Equivalent | Xenco Medical, LLC. |
| K181347 | Aries® Lumbar Interbodies | Aug 15, 2018 | Substantially Equivalent | Osseus Fusion Systems, LLC |
| K181792 | Duo Lumbar Interbody Fusion Device | Aug 14, 2018 | Substantially Equivalent | Spineology Inc. |
| K180990 | TirboLOX-L Lumbar IBFD | Aug 13, 2018 | Substantially Equivalent | Captiva Spine, Inc. |
| K180777 | K2M Expandable Interbody System | Aug 03, 2018 | Substantially Equivalent | K2M, Inc. |
| K180556 | Corelink Foundation 3D Anterior Lumbar System | Jul 27, 2018 | Substantially Equivalent | Corelink, LLC |
| K180076 | Ti 3Z Interbody System | Jul 27, 2018 | Substantially Equivalent | Zavation Medical Products, LLc |
| K181453 | ATEC ALIF Spacer System | Jul 25, 2018 | Substantially Equivalent | Alphatec Spine, Inc. |
| K173947 | Lumbar Interbody Fusion System (OLLIF) | Jul 25, 2018 | Substantially Equivalent | Advanced Research Medical, LLC |
| K181079 | SeaSpine Regatta Lateral System | Jul 18, 2018 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K181014 | Tritanium PL Cage | Jul 18, 2018 | Substantially Equivalent | Stryker Spine |
| K181030 | Rubicon Lumbar Interbody Fusion System | Jul 17, 2018 | Substantially Equivalent | Rubicon Spine, LLC |
| K180963 | ROCCIA ALIF, ROCCIA TLIF | Jul 11, 2018 | Substantially Equivalent | Silony Medical GmbH |
| K181246 | Zavation IBF System | Jul 10, 2018 | Substantially Equivalent | Zavation Medical Products LLC |
| K173864 | Peekplus® Interbody Fusion Device | Jul 02, 2018 | Substantially Equivalent | Vallum Corporation |
| K181203 | Juliet Ti | Jun 28, 2018 | Substantially Equivalent | Spineart |
| K180724 | SPIRA Open Matrix LLIF | Jun 25, 2018 | Substantially Equivalent | Camber Spine Technologies LLC |
| K173189 | Lumfuse TP | Jun 08, 2018 | Substantially Equivalent | Precifit Medical Ltd |
| K180687 | Reliance Lumber IBF System | May 15, 2018 | Substantially Equivalent | Reliance Medical Systems |
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX | May 08, 2018 | Substantially Equivalent | Centinel Spine, Inc. |
| K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System | May 04, 2018 | Substantially Equivalent | Cutting Edge Spine, LLC |
| K180437 | Hexanium® TLIF | May 04, 2018 | Substantially Equivalent | SpineVision, SAS |
| K173892 | NuVasive® XLX Interbody System | May 04, 2018 | Substantially Equivalent | NuVasive, Incorporated |
| K180071 | STYLO Interbody Fusion Device | May 03, 2018 | Substantially Equivalent | Legend Spine Technologies |
| K171151 | ACRON TLIF System | Apr 27, 2018 | Substantially Equivalent | SpineMED Ges.m.b.H |
| K173782 | UNiD Patient Specific 3D printed cage | Apr 25, 2018 | Substantially Equivalent | Medicrea International S.A. |
| K172947 | HALF DOME Posterior Lumbar Interbody System | Apr 18, 2018 | Substantially Equivalent | Astura Medical |
| K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | Apr 17, 2018 | Substantially Equivalent | Innovasis, Inc. |
| K180431 | Cortina [MAX] Lumbar Cage System | Mar 22, 2018 | Substantially Equivalent | NeuroStructures, Inc. |
| K171495 | Zyston Strut Open Titanium Spacer System | Feb 12, 2018 | Substantially Equivalent | Zimmer Biomet Spine Inc. |
| K173537 | CONCORDE LIFT | Feb 08, 2018 | Substantially Equivalent | Medos International, SARL |
| K173025 | NuVasive® MLX® Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System | Feb 08, 2018 | Substantially Equivalent | NuVasive, Incorporated |
| K172105 | The Plateau-LO Spacer System | Feb 02, 2018 | Substantially Equivalent | Life Spine Inc. |
| K172828 | Double Medical Cage System | Feb 01, 2018 | Substantially Equivalent | Double Medical Technology Inc |
| K172816 | TiGer Shark System | Jan 26, 2018 | Substantially Equivalent | Choice Spine, LP. |
| K171312 | FortiCore® | Jan 22, 2018 | Substantially Equivalent | Nanovis LLC |
| K173283 | Reliance Lumbar IBF System | Jan 19, 2018 | Substantially Equivalent | Reliance Medical Systems, LLC |
| K172696 | FORZA® XP Expandable Spacer System | Jan 19, 2018 | Substantially Equivalent | Orthofix Inc. |
| K173476 | Tritanium® TL Curved Posterior Lumbar Cage | Jan 18, 2018 | Substantially Equivalent | Stryker |
| K173702 | Juliet Ti LL | Jan 03, 2018 | Substantially Equivalent | SPINEART |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers | Dec 21, 2017 | Substantially Equivalent | Globus Medical Inc. |
| K171434 | ROCCIA® MultiLIF | Dec 21, 2017 | Substantially Equivalent | Silony Medical GmbH |
| K173182 | ProLift® Expandable System | Dec 20, 2017 | Substantially Equivalent | Life Spine Inc. |
| K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages | Dec 15, 2017 | Substantially Equivalent | EIT Emerging Implant Technologies GmbH |
| K172465 | Idys TLIF 3DTi Cages | Dec 15, 2017 | Substantially Equivalent | CLARIANCE, SAS |
| K172349 | InFill® Interbody Fusion Device | Dec 14, 2017 | Substantially Equivalent | Pinnacle Spine Group, LLC |
| K172009 | Cascadia Interbody System | Dec 14, 2017 | Substantially Equivalent | K2M, Inc. |
| K170389 | TAURUS PEEK Cage System | Dec 14, 2017 | Substantially Equivalent | Medyssey USA, Inc. |
| K172756 | Varian cage | Dec 08, 2017 | Substantially Equivalent | Medyssey USA, Inc. |
| K173153 | Vertera Spine Coalesce Thoracolumbar Interbody Fusion System | Dec 06, 2017 | Substantially Equivalent | NuVasive, Incorporated |
| K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System | Dec 04, 2017 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K172419 | Velofix TLIF Cage | Dec 04, 2017 | Substantially Equivalent | U&i Corporation |
| K170553 | Altus Spine Interbody Fusion System | Dec 01, 2017 | Substantially Equivalent | Altus Partners, LLC |
| K172020 | Arlington PLIF/TLIF Cage | Nov 29, 2017 | Substantially Equivalent | Signature Orthopaedics Pty Ltd. |
| K170235 | Lucent® | Nov 29, 2017 | Substantially Equivalent | Spinal Elements Inc. |
| K163595 | IMPIX 3D Print Cages | Nov 13, 2017 | Substantially Equivalent | MEDICREA INTERNATIONAL S.A. |
| K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion Device | Nov 07, 2017 | Substantially Equivalent | 4Web, Inc. |
| K170341 | Medussa-PL Cage | Nov 02, 2017 | Substantially Equivalent | Medyssey USA, Inc. |
| K173080 | IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) | Oct 31, 2017 | Substantially Equivalent | Huvexel Co., Ltd |
| K173022 | SeaSpine Ventura NanoMetalene System | Oct 26, 2017 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K172341 | NuVasive® Modulus TLIF Interbody System | Oct 26, 2017 | Substantially Equivalent | NuVasive, Incorporated |
| K172334 | Ortus Expandable Lumbar Interbody Fusion System | Oct 25, 2017 | Substantially Equivalent | Atlas Spine, Inc. |
| K171914 | Cortina Lumbar Cage System | Oct 25, 2017 | Substantially Equivalent | NeuroStructures, Inc. |
| K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | Oct 23, 2017 | Substantially Equivalent | RTI Surgical, Inc. |
| K172123 | NuVasive® Modulus XLIF Interbody System | Oct 11, 2017 | Substantially Equivalent | NuVasive, Incorporated |
| K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | Oct 05, 2017 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. |
| K170119 | Calix Lumbar Spinal Implant System | Sep 29, 2017 | Substantially Equivalent | X-Spine Systems, Inc. |
| K171633 | NuVasive TLX Interbody System | Sep 28, 2017 | Substantially Equivalent | NuVasive, Incorporated |
| K171107 | CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System | Sep 26, 2017 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium | Sep 19, 2017 | Substantially Equivalent | Medtronic Sofamor Danek |
| K172064 | Ti-Diagon Oblique TLIF | Sep 15, 2017 | Substantially Equivalent | Camber Spine Technologies |
| K171519 | FLXfit | Sep 15, 2017 | Substantially Equivalent | Expanding Orthopedics, Inc. |
| K171893 | Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) | Sep 08, 2017 | Substantially Equivalent | Bluestone Synergy |
| K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion Device | Sep 08, 2017 | Substantially Equivalent | 4Web, Inc. |
| K171329 | Altus Spine Titanium Interbody Fusion System | Aug 29, 2017 | Substantially Equivalent | Altus Partners, LLC |
| K171660 | Duo Lumbar Interbody Fusion Device | Aug 18, 2017 | Substantially Equivalent | Spineology Inc. |
| K171657 | ShurFit 2C Lumbar Interbody Fusion System | Aug 11, 2017 | Substantially Equivalent | Precision Spine, Inc. |
| K170888 | Renovis S141 Lumbar Interbody Fusion System | Aug 08, 2017 | Substantially Equivalent | Renovis Surgical Technologies |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | Aug 07, 2017 | Substantially Equivalent | 4Web, Inc. |
| K170919 | The TiBow Expandable Spacer System | Aug 03, 2017 | Substantially Equivalent | Life Spine Inc. |
| K171630 | LumFuse-TP | Jul 25, 2017 | Substantially Equivalent | Precifit Medical Ltd |
| K171724 | Rampart L Lumbar Interbody Fusion Device | Jul 24, 2017 | Substantially Equivalent | Spineology Inc. |
| K171425 | CONCORDE LIFT | Jul 20, 2017 | Substantially Equivalent | Medos International, SARL |
| K171656 | Genesys Spine Apache Interbody Fusion System | Jul 13, 2017 | Substantially Equivalent | Genesys Spine |
| K170676 | HD Lumbar Interbody System | Jul 13, 2017 | Substantially Equivalent | HD LifeSciences LLC |
| K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages | Jul 11, 2017 | Substantially Equivalent | EIT Emerging Implant Technologies GmbH |
| K171031 | CRESCENT Spinal System | Jul 06, 2017 | Substantially Equivalent | Medtronic Sofamor Danek |
| K170399 | Endoskeleton TO Interbody Fusion Device (IBD) | Jul 06, 2017 | Substantially Equivalent | Titan Spine, LLC |
| K161710 | SAGICO IBF SYSTEM ARIA LUMBAR, SAGICO IBF SYSTEM ARION CERVICAL | Jun 29, 2017 | Substantially Equivalent | SPINAL ANALYTICS & GEOMETRICAL IMPANT CO, LLC |
| K170297 | Tranquil Interbody System | Jun 27, 2017 | Substantially Equivalent | Nexus Spine, LLC |
| K170962 | NuVasive® CoRoent® Thoracolumbar System | Jun 26, 2017 | Substantially Equivalent | NuVasive, Incorporated |
| K163506 | Coalesce (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System | Jun 19, 2017 | Substantially Equivalent | Vertera, Inc. |
| K171468 | FUSE Spinal System | Jun 13, 2017 | Substantially Equivalent | Medtronic Sofamor Danek |
| K162986 | SPIRA Open Matrix ALIF | Jun 12, 2017 | Substantially Equivalent | CAMBER SPINE TECHNOLOGIES |
| K170890 | TELIX K Interbody System | Jun 02, 2017 | Substantially Equivalent | Biedermann Motech GmbH & Co. KG |
| K170395 | Talos® Lumbar (HA) PEEK IBF Devices | Jun 02, 2017 | Substantially Equivalent | Meditech Spine, LLC |
| K162212 | DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM | May 19, 2017 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K171097 | MOJAVE Expandable Interbody System | May 10, 2017 | Substantially Equivalent | K2M, Inc. |
| K163481 | HALF DOME Posterior Lumbar Interbody System | May 03, 2017 | Substantially Equivalent | Astura Medical |
| K163707 | NuVasive CoRoent Ti-C System | May 01, 2017 | Substantially Equivalent | NuVasive, Incorporated |
| K170572 | Summit Spine Yellowstone Lumbar Interbody Fusion System | Apr 26, 2017 | Substantially Equivalent | Summit Spine |
| K170511 | NeoFuse HA Enhanced PLIF/TLIF | Apr 25, 2017 | Substantially Equivalent | HT Medical, LLC |
| K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | Apr 14, 2017 | Substantially Equivalent | RTI Surgical, Inc. dba RTI Biologics |
| K163386 | Keos Lumbar IBFD | Apr 10, 2017 | Substantially Equivalent | Keos |
| K163246 | Leva Anterior Expandable Spacer System | Apr 06, 2017 | Substantially Equivalent | SPINE WAVE, INC. |
| K162206 | Zavation IBF | Apr 04, 2017 | Substantially Equivalent | Zavation, LLC |
| K170243 | LOSPA IS TLIF & DLIF Cages | Mar 31, 2017 | Substantially Equivalent | CORENTEC CO., LTD |
| K162693 | VertebraLINK Fusion Platform | Mar 29, 2017 | Substantially Equivalent | FACETLINK DBA LINKSPINE |
| K163230 | NuVasive Modulus XLIF Interbody System | Mar 16, 2017 | Substantially Equivalent | NUVASIVE INCORPORATED |
| K163364 | MOJAVE Expandable Interbody System | Mar 15, 2017 | Substantially Equivalent | K2M |
| K170512 | Altus Spine Titanium Interbody Fusion System | Mar 10, 2017 | Substantially Equivalent | Altus Partners, LLC |
| K163409 | Rampart(TM) T Lumbar Interbody Fusion Device | Mar 08, 2017 | Substantially Equivalent | Spineology Inc. |
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT Spacers, ALTERA Spacers, MAGNIFY Spacers, InterContinental® Plate-Spacer | Feb 22, 2017 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K162918 | Atlas Spine Expandable Interbody System | Feb 09, 2017 | Substantially Equivalent | Atlas Spine, Inc. |
| K162879 | Elite Expandable Interbody Fusion Device | Jan 30, 2017 | Substantially Equivalent | Spineology Inc. |
| K160976 | Altus Spine Interbody Fusion System | Jan 25, 2017 | Substantially Equivalent | ALTUS PARTNERS, LLC |
| K163180 | Hubble II | Dec 29, 2016 | Substantially Equivalent | Orbbo Surgical, LLC |
| K162446 | FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System | Dec 22, 2016 | Substantially Equivalent | ORTHOFIX INC. |
| K162327 | COUGAR® LS Lateral Cage System and COUGAR® System | Dec 12, 2016 | Substantially Equivalent | Medos International, Sarl |
| K162103 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye) | Nov 23, 2016 | Substantially Equivalent | CHOICE SPINE, LP |
| K162431 | Luna 3D Interbody Fusion System | Nov 17, 2016 | Substantially Equivalent | Benvenue Medical, Inc. |
| K160959 | Xsert Lumbar Expandable Interbody System | Nov 17, 2016 | Substantially Equivalent | X-SPINE SYSTEMS, INC. |
| K160663 | Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) | Nov 16, 2016 | Substantially Equivalent | EVOLUTION SPINE, LLC |
| K162262 | Tritanium® PL Cage | Nov 09, 2016 | Substantially Equivalent | STRYKER |
| K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System | Nov 08, 2016 | Substantially Equivalent | GENESYS SPINE |
| K160924 | Amendia Interbody Fusion Devices | Nov 08, 2016 | Substantially Equivalent | AMENDIA, INC. |
| K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | Nov 01, 2016 | Substantially Equivalent | SYNTHES USA PRODUCTS LLC |
| K162715 | SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene | Oct 28, 2016 | Substantially Equivalent | SeaSpine Orthopedics Corporation |
| K160074 | Rampart D Lumbar Interbody Fusion Device | Oct 18, 2016 | Substantially Equivalent | Spineology Inc. |
| K160076 | XCage Interbody Fusion System | Oct 13, 2016 | Substantially Equivalent | Ouroboros Medical, Inc. |
| K162426 | nva, nvp, and nvt | Sep 29, 2016 | Substantially Equivalent | NVISION BIOMEDICAL TECHNOLOGIES, LLC |
| K162264 | Cascadia Interbody System | Sep 21, 2016 | Substantially Equivalent | K2M, Inc. |
| K153665 | PROW FUSION-L | Sep 15, 2016 | Substantially Equivalent | NLT SPINE LTD |
| K161888 | JULIET® LL Lateral Lumbar Cage | Sep 12, 2016 | Substantially Equivalent | SPINEART |
| K161485 | Nanovis Intervertebral Body Fusion System and Forticore(R) | Sep 06, 2016 | Substantially Equivalent | NANOVIS LLC |
| K161230 | NuVasive Lumbar Interbody Implants | Aug 25, 2016 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K160646 | XYcor® Expandable Spinal Spacer System | Aug 24, 2016 | Substantially Equivalent | Alphatec Spine, Inc |
| K161405 | Valeo II Interbody Fusion Device System | Aug 19, 2016 | Substantially Equivalent | AMEDICA CORP. |
| K160856 | SpineView X-Pac Expandable Lumbar Cage System | Aug 01, 2016 | Substantially Equivalent | Spine View, Inc. |
| K160699 | VIRTU Lumbar Spacer System | Aug 01, 2016 | Substantially Equivalent | Met 1 Technologies, LLC |
| K161404 | Genesys Spine Apache® Lateral Lumbar Interbody Fusion System | Jul 21, 2016 | Substantially Equivalent | Genesys Spine |
| K160955 | Tritanium® PL Cage | Jul 21, 2016 | Substantially Equivalent | STRYKER |
| K160631 | Keos Lumbar IBFD | Jul 15, 2016 | Substantially Equivalent | KEOS |
| K153621 | Juliet® Ti | Jul 15, 2016 | Substantially Equivalent | SPINEART |
| K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device | Jul 14, 2016 | Substantially Equivalent | SPINEOLOGY INC. |
| K153786 | PROW FUSION-V | Jul 11, 2016 | Substantially Equivalent | NLT SPINE LTD |
| K153105 | MLX - Medial Lateral Expandable Lumbar Interbody System | Jul 11, 2016 | Substantially Equivalent | NuVasive, Incorporated |
| K160715 | AccuLIF TL and PL Cage | Jul 08, 2016 | Substantially Equivalent | STRYKER CORPORATION |
| K152501 | Spinal Jaxx Interbody Fusion Device | Jun 29, 2016 | Substantially Equivalent | NEUROPRO SPINAL JAXX, INC. |
| K160916 | CoRoent® Ti-C System | Jun 28, 2016 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K160874 | Nanovis Intervertebral Body Fusion System and FortiCore® | Jun 28, 2016 | Substantially Equivalent | NANOVIS LLC |
| K152011 | Lucent Intervertebral Body Fusion Device | Jun 09, 2016 | Substantially Equivalent | Spinal Elements Inc. |
| K153436 | LATERAL Spine Truss System | Jun 06, 2016 | Substantially Equivalent | 4Web, Inc. |
| K160463 | Reliance Lumbar IBF System | May 20, 2016 | Substantially Equivalent | Reliance Medical Systems, LLC |
| K153107 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System | May 19, 2016 | Substantially Equivalent | CHOICE SPINE, LP |
| K153615 | NeoFuse HA Enhanced PLIF/TLIF | May 06, 2016 | Substantially Equivalent | HT MEDICAL, LLC |
| K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF | May 04, 2016 | Substantially Equivalent | SpineVision S.A. |
| K153123 | Genesys Spine Apache Interbody Fusion System | Apr 26, 2016 | Substantially Equivalent | GENESYS SPINE |
| K153222 | Leva Spacer System | Apr 15, 2016 | Substantially Equivalent | SPINE WAVE, INC. |
| K153419 | NuVasive CoRoent Thoracolumbar System | Apr 13, 2016 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer | Apr 13, 2016 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K160464 | Opticage(R) Expandable Interbody Fusion Device | Apr 04, 2016 | Substantially Equivalent | INTERVENTIONAL SPINE, INC. |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System | Mar 31, 2016 | Substantially Equivalent | LDR Spine USA |
| K152200 | SurgTech Interbody System | Mar 25, 2016 | Substantially Equivalent | SURGTECH INC |
| K160547 | Cascadia Interbody System | Mar 24, 2016 | Substantially Equivalent | K2M |
| K153782 | NuVasive® Lumbar Interbody Implants | Mar 24, 2016 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K153627 | NuVasive® TLX Interbody System | Mar 17, 2016 | Substantially Equivalent | NUVASIVE INCORPORATED |
| K151665 | SUSTAIN Additional Implants | Mar 16, 2016 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K160418 | PERIMETER Interbody Fusion Device | Mar 07, 2016 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc |
| K153400 | ProLift Expandable System | Mar 07, 2016 | Substantially Equivalent | LIFE SPINE, INC. |
| K151406 | Cogent Lateral Interbody System | Feb 25, 2016 | Substantially Equivalent | COGENT SPINE LLC |
| K152539 | SpineView X-Pac Expandable Lumbar Cage System | Feb 24, 2016 | Substantially Equivalent | SPINE VIEW, INC. |
| K153082 | Rampart A Lumbar Interbody Fusion Device | Feb 04, 2016 | Substantially Equivalent | SPINEOLOGY, INC. |
| K152512 | Half Dome Posterior Lumbar Interbody System | Jan 28, 2016 | Substantially Equivalent | Astura Medical |
| K153695 | Biomet Spine Fusion System | Jan 21, 2016 | Substantially Equivalent | Biomet Spine LLC. |
| K151726 | AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer | Jan 20, 2016 | Substantially Equivalent | Stryker Corporation |
| K152620 | Spine Wave Gen II Expandable Interbody System | Jan 15, 2016 | Substantially Equivalent | SPINE WAVE, INC. |
| K153356 | Spine Innovation Interbody System | Jan 14, 2016 | Substantially Equivalent | Spine Innovation LLC |
| K152475 | FORZA PTC Spacer System | Jan 14, 2016 | Substantially Equivalent | ORTHOFIX INC. |
| K151310 | Amendia Interbody Fusion Devices | Jan 06, 2016 | Substantially Equivalent | AMENDIA, INC. |
| K152651 | AccuLIF TL and PL Cage | Dec 15, 2015 | Substantially Equivalent | STRYKER CORPORATION |
| K151900 | VariLift-L Interbody Fusion Device | Dec 11, 2015 | Substantially Equivalent | WENZEL SPINE, INC. |
| K152355 | Twin Peaks Lumbar Interbody Fusion System | Dec 10, 2015 | Substantially Equivalent | SPINEWAY |
| K151773 | CONCORDE Bullet Lumbar Interbody System | Nov 20, 2015 | Substantially Equivalent | Medos International, Sarl |
| K152304 | Tritanium PL Cage | Nov 19, 2015 | Substantially Equivalent | Stryker |
| K152259 | InFill Interbody Fusion Device | Nov 19, 2015 | Substantially Equivalent | Pinnacle Spine Group, LLC |
| K152277 | PIVOX(tm) Oblique Lateral Spinal System | Nov 13, 2015 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC |
| K151819 | Integrity Spine Lumbar Interbody Fusion System | Nov 10, 2015 | Substantially Equivalent | INTEGRITY SPINE LUMBAR INTERBODY FUSION SYSTEM |
| K152156 | Opticage Expandable Interbody Fusion Device | Oct 19, 2015 | Substantially Equivalent | INTERVENTIONAL SPINE, INC. |
| K151785 | Px HA PEEK IBF System | Oct 14, 2015 | Substantially Equivalent | INNOVASIS, INC. |
| K151352 | CONCORDE Bullet Spinal System | Oct 08, 2015 | Substantially Equivalent | MEDOS INTERNATIONAL SARL |
| K151408 | LOSPA IS Spinal System | Oct 02, 2015 | Substantially Equivalent | CORENTEC CO., LTD |
| K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device System | Oct 02, 2015 | Substantially Equivalent | Amedica Corp. |
| K143479 | Bluefin Interbody System | Sep 25, 2015 | Substantially Equivalent | Tides Medical |
| K151472 | NuVasive CoRoent Lumbar System | Sep 10, 2015 | Substantially Equivalent | NuVasive, Incorporated |
| K151322 | Amendia Interbody Fusion Devices | Sep 10, 2015 | Substantially Equivalent | AMENDIA, INC. |
| K151756 | STERISPINE LC CAGE | Aug 21, 2015 | Substantially Equivalent | SAFE ORTHOPAEDICS |
| K150481 | Cascadia Interbody System | Aug 20, 2015 | Substantially Equivalent | K2M, Inc. |
| K151140 | LnK Lumbar Interbody Fusion Cage System | Aug 18, 2015 | Substantially Equivalent | L&K BIOMED Co., Ltd |
| K151056 | Aesculap T-Space PEEK and XP Spinal System | Aug 13, 2015 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, LLC |
| K150395 | Omega LIF System | Aug 10, 2015 | Substantially Equivalent | AMENDIA, INC. |
| K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System | Aug 06, 2015 | Substantially Equivalent | NuVasive, Incorporated |
| K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal System | Aug 06, 2015 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC |
| K151483 | Biomet Spine Fusion System | Jul 31, 2015 | Substantially Equivalent | Biomet Spine LLC. |
| K151020 | Rampart-T Interbody Fusion System | Jul 22, 2015 | Substantially Equivalent | Spineology, Inc. |
| K143143 | PATHWAY ELIF | Jul 22, 2015 | Substantially Equivalent | CUSTOM SPINE, INC. |
| K151654 | PROW FUSION | Jul 17, 2015 | Substantially Equivalent | NLT SPINE LTD |
| K151184 | InFill Interbody Fusion Devices | Jul 14, 2015 | Substantially Equivalent | PINNACLE SPINE GROUP, LLC |
| K150321 | EVOS Lumbar Interbody System | Jul 13, 2015 | Substantially Equivalent | Cutting Edge Spine, LLC |
| K151581 | Leva Spacer System | Jul 09, 2015 | Substantially Equivalent | SPINE WAVE, INC. |
| K151143 | EndoLIF On-Cage | Jul 09, 2015 | Substantially Equivalent | JOIMAX GMBH |
| K150500 | Px PEEK IBF System | Jun 19, 2015 | Substantially Equivalent | INNOVASIS, INC. |
| K151276 | DePuy Synthes T-PAL Ti Spacer | Jun 18, 2015 | Substantially Equivalent | SYNTHES USA PRODUCTS LLC |
| K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Jun 11, 2015 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K142559 | ELEVATE Spinal System | Jun 09, 2015 | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. |
| K143740 | Battalion Universal Spacer System | May 22, 2015 | Substantially Equivalent | ALPHATEC SPINE, INC. |
| K150061 | Lucent; Lucent Ti-Bond Systems | May 19, 2015 | Substantially Equivalent | Spinal Elements Inc. |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device System | May 13, 2015 | Substantially Equivalent | SpineFrontier, Inc. |
| K150152 | The Octane Straight Intervertebral Fusion Device, Ti Coated | May 11, 2015 | Substantially Equivalent | EXACTECH, INC. |
| K150954 | Elite L Expandable Lumbar Fusion System | May 07, 2015 | Substantially Equivalent | INNOVA SPINAL TECHNOLOGIES, LLC |
| K143595 | NuVasive(R) CCX-L Interbody System | Apr 29, 2015 | Substantially Equivalent | NuVasive, Incorporated |
| K142392 | Zavation Posterior LEIF | Apr 29, 2015 | Substantially Equivalent | ZAVATION, LLC |
| K140348 | INTERBODY CAGE | Apr 23, 2015 | Substantially Equivalent | EISERTECH, LLC |
| K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | Apr 09, 2015 | Substantially Equivalent | 4WEB,INC. |
| K150206 | InFill Interbody Fusion Devices | Apr 03, 2015 | Substantially Equivalent | PINNACLE SPINE GROUP, LLC |
| K143158 | Xenco Medical Lumbar Interbody System | Mar 20, 2015 | Substantially Equivalent | Xenco Medical, LLC |
| K141665 | NuVasive CoRoent System | Mar 13, 2015 | Substantially Equivalent | NUVASIVE, INC. |
| K142634 | Biomet Spine Fusion System | Mar 12, 2015 | Substantially Equivalent | BIOMET SPINE, LLC. |
| K150285 | Leva(TM) Spacer System | Mar 05, 2015 | Substantially Equivalent | SPINE WAVE, INC. |
| K143616 | AccuLIF TL and PL Cage | Mar 05, 2015 | Substantially Equivalent | STRYKER CORPORATION |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) | Feb 12, 2015 | Substantially Equivalent | Zimmer Spine, Inc. |
| K143126 | Renovis S141 Lumbar Interbody Cage System | Feb 06, 2015 | Substantially Equivalent | Renovis Surgical Technologies |
| K141980 | LEVA (TM) SPACER SYSTEM | Jan 26, 2015 | Substantially Equivalent | SPINE WAVE, INC. |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene | Dec 18, 2014 | Substantially Equivalent | SeaSpine, Inc. |
| K141135 | JULIET LL | Dec 01, 2014 | Substantially Equivalent | SPINEART |
| K142594 | nva, nvp, nvt | Nov 28, 2014 | Substantially Equivalent | NVISION BIOMEDICAL TECHNOLOGIES, LLC |
| K140716 | OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE | Nov 24, 2014 | Substantially Equivalent | INTERVENTIONAL SPINE, INC. |
| K142023 | LUNA INTERBODY SYSTEM | Nov 20, 2014 | Substantially Equivalent | BENVENUE MEDICAL, INC. |
| K141896 | COROENT SYSTEM | Nov 20, 2014 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K142347 | Amedica Valeo II Interbody Fusion Device | Nov 18, 2014 | Substantially Equivalent | Amedica Corp |
| K141953 | ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL | Oct 27, 2014 | Substantially Equivalent | TITAN SPINE, LLC |
| K142101 | ABACUS (TM) SPACER SYSTEM | Oct 23, 2014 | Substantially Equivalent | SPINE WAVE, INC. |
| K142589 | Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL | Oct 17, 2014 | Substantially Equivalent | TITAN SPINE, LLC |
| K142193 | COGENT MED-LIF XL | Oct 15, 2014 | Substantially Equivalent | COGENT SPINE LLC |
| K142277 | JULIET PO | Oct 14, 2014 | Substantially Equivalent | SPINEART |
| K140319 | COROENT TI-C SYSTEM | Oct 09, 2014 | Substantially Equivalent | NUVASIVE, INC. |
| K140577 | INNESIS PEEK TL CAGE | Oct 01, 2014 | Substantially Equivalent | BK MEDITECH CO., LTD. |
| K133577 | CLYDESDALE(R) SPINAL SYSTEM | Sep 26, 2014 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC |
| K142112 | 4WEB SPINAL IMPLANT PRODUCTS | Sep 23, 2014 | Substantially Equivalent | 4WEB, INC. |
| K133717 | LONGBOW SPACER SYSTEM | Sep 19, 2014 | Substantially Equivalent | LIFE SPINE |
| K141405 | MOBIS II ST SPINAL IMPLANT | Sep 16, 2014 | Substantially Equivalent | SIGNUS MEDIZINTECHNIK GMBH |
| K141443 | INFRONT LUMBAR INTERBODY FUSION SYSTEM | Aug 28, 2014 | Substantially Equivalent | INFRONT MEDICAL, LLC |
| K140770 | MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM | Jul 25, 2014 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K132907 | PLIF LITE AND TLIF LITE | Jul 24, 2014 | Substantially Equivalent | SINTEA PLUSTEK |
| K141217 | ACCULIF TL AND PL CAGE | Jul 16, 2014 | Substantially Equivalent | STRYKER CORPORATION |
| K140142 | CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) | Jul 16, 2014 | Substantially Equivalent | CHOICE SPINE, LP |
| K133813 | FLXFIT INTERVERTEBRAL BODY FUSION DEVICE | Jul 15, 2014 | Substantially Equivalent | EXPANDING ORTHOPEDICS, INC. |
| K133053 | MILESTONE SPINAL SYSTEM | Jul 15, 2014 | Substantially Equivalent | WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
| K140162 | AP EXPANDABLE XLIF SYSTEM | Jul 02, 2014 | Substantially Equivalent | NUVASIVE, INC. |
| K140055 | ENDOSKELETON(R) TL INTERBODY FUSION DEVICE | Jul 02, 2014 | Substantially Equivalent | TITAN SPINE, LLC |
| K140411 | ALTERA SPACER | Jul 01, 2014 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K140659 | COROENT THORACOLUMBAR IMPLANTS | Jun 26, 2014 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K140759 | BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL | Jun 13, 2014 | Substantially Equivalent | MEDOS INTERNATIONAL, SARL |
| K140564 | BN LUMBAR CAGE SYSTEM | Jun 05, 2014 | Substantially Equivalent | MEDYSSEY USA, INC. |
| K132852 | PEEK CAGE FOR THE VERTEBRAL SPINE | May 29, 2014 | Substantially Equivalent | NEOORTHO PRODUTOS ORTOPEDICOS S/A |
| K140709 | SKYHAWK INTERBODY FUSION SYSTEM | May 27, 2014 | Substantially Equivalent | ORTHOFIX INC. |
| K133514 | XCAGE INTERBODY FUSION SYSTEM | May 01, 2014 | Substantially Equivalent | OUROBOROS MEDICAL |
| K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM | May 01, 2014 | Substantially Equivalent | SEASPINE, INC. |
| K123607 | OCTANE ELEVATE SPINAL IMPLANT SYSTEM | Apr 25, 2014 | Substantially Equivalent | EXACTECH, INC. |
| K140303 | ALAMO T | Apr 21, 2014 | Substantially Equivalent | ALLIANCE PARTNERS, LLC. |
| K140474 | JULIET OL | Apr 18, 2014 | Substantially Equivalent | SPINEART |
| K131612 | ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES | Apr 18, 2014 | Substantially Equivalent | GS MEDICAL CO., LTD. |
| K132738 | COGENT MED-LIF | Apr 15, 2014 | Substantially Equivalent | COGENT SPINE LLC |
| K133340 | SPINEWORKS ANTERIOR LUMBAR DEVICE | Apr 11, 2014 | Substantially Equivalent | SPINEWORKS, LLC |
| K140007 | ABACUS TM SPACER SYSTEM | Apr 07, 2014 | Substantially Equivalent | SPINE WAVE, INC. |
| K133614 | ALEUTIAN IBF SYSTEM | Apr 03, 2014 | Substantially Equivalent | K2M, INC. |
| K133721 | INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 | Mar 31, 2014 | Substantially Equivalent | PINNACLE SPINE GROUP, LLC |
| K133455 | CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC | Mar 27, 2014 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY, INC |
| K134038 | CAMBER SPINE DIAGON OBLIQUE CAGE | Mar 20, 2014 | Substantially Equivalent | CAMBER SPINE |
| K133893 | STERISPINE LC CAGE | Mar 14, 2014 | Substantially Equivalent | SAFE ORTHOPAEDICS |
| K133205 | CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM | Mar 13, 2014 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K133459 | ELITE IBF | Mar 06, 2014 | Unknown | INNOVA SPINAL TECHNOLOGIES, LLC |
| K133583 | OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 | Feb 10, 2014 | Substantially Equivalent | INTERVENTIONAL SPINE, INC. |
| K133557 | JULIET LL LATERAL LUMBAR CAGE | Feb 03, 2014 | Substantially Equivalent | SPINEART |
| K131292 | DEROYAL SPINE SPACER SYSTEM | Feb 03, 2014 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K133967 | INTERBODY CAGE SYSTEM | Jan 31, 2014 | Substantially Equivalent | AURORA SPINE |
| K133192 | MECTALIF TIPEEK | Jan 30, 2014 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K133184 | ARDIS INTERBODY SYSTEM | Jan 30, 2014 | Substantially Equivalent | ZIMMER SPINE, INC |
| K132421 | AESCULAP PEEK XP SPINAL IMPLANT SYSTEM | Jan 22, 2014 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, INC. |
| K133371 | RAMPART-L | Jan 09, 2014 | Substantially Equivalent | SPINEOLOGY, INC. |
| K133645 | PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM | Jan 03, 2014 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K132601 | COROENT STERILE IMPLANTS SYSTEM | Dec 24, 2013 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K133650 | CAPSTONE SPINAL SYSTEM | Dec 20, 2013 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K132790 | INFIX ANTERIOR LUMBAR SYSTEM | Dec 20, 2013 | Substantially Equivalent | ZIMMER SPINE, INC |
| K130913 | GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM | Dec 13, 2013 | Substantially Equivalent | GENESYS SPINE |
| K132897 | CLYDESDALE SPINAL SYSTEM | Dec 11, 2013 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K133126 | K7 LUMBAR SPACERS | Dec 09, 2013 | Substantially Equivalent | K7 LLC |
| K133216 | CRESCENT SPINAL SYSTEM | Nov 22, 2013 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K131669 | PERIMETER INTERBODY FUSION DEVICE | Nov 01, 2013 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K130274 | BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM | Oct 29, 2013 | Substantially Equivalent | ELITE SURGICAL SUPPLIES (PTY) LTD. |
| K131350 | CALIX LUMBAR SPINAL IMPLANT SYSTEM | Oct 23, 2013 | Substantially Equivalent | X-SPINE SYSTEMS, INC |
| K130254 | PROW FUSION | Oct 16, 2013 | Substantially Equivalent | NLT SPINE LTD |
| K131178 | IDYS LIF CAGES | Oct 10, 2013 | Substantially Equivalent | CLARIANCE |
| K131981 | CEZANNE II INTERBODY FUSION SYSTEM | Oct 09, 2013 | Substantially Equivalent | ACCEL SPINE |
| K132719 | STAXX IBL SYSTEM | Oct 04, 2013 | Substantially Equivalent | SPINE WAVE, INC. |
| K132700 | PERIMETER INTERBODY FUSION DEVICE | Sep 26, 2013 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K132479 | OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 | Sep 19, 2013 | Substantially Equivalent | INTERVENTIONAL SPINE, INC. |
| K132053 | RAMPART-O, RAMPART-T | Sep 16, 2013 | Substantially Equivalent | SPINEOLOGY, INC. |
| K132505 | ACCULIF TL AND PL CAGE | Sep 12, 2013 | Substantially Equivalent | COALIGN INNOVATIONS, INC. |
| K131540 | INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE | Sep 03, 2013 | Substantially Equivalent | VERTEBRAL TECHNOLOGIES, INC. |
| K131296 | VARILIFT-L INTERBODY FUSION DEVICE | Sep 03, 2013 | Substantially Equivalent | WENZEL SPINE, INC. |
| K131242 | ARDIS INTERBODY SYSTEM | Sep 03, 2013 | Substantially Equivalent | ZIMMER SPINE, INC |
| K131082 | INTERFORM INTERBODY CAGE SYSTEM | Aug 26, 2013 | Substantially Equivalent | NEXT ORTHOSURGICAL |
| K131071 | STAXX IBL SYSTEM | Aug 20, 2013 | Substantially Equivalent | SPINE WAVE, INC. |
| K130820 | EXPANDABLE LUMBAR INTERBODY SYSTEM | Aug 08, 2013 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K130478 | SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS | Jul 26, 2013 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K123027 | CAPSTONE(R) SPINAL SYSTEM | Jul 25, 2013 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K131077 | LIFE SPINE PLATEAU SPACER SYSTEM | Jul 17, 2013 | Substantially Equivalent | LIFE SPINE |
| K131671 | MECTALIF | Jul 05, 2013 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K131372 | MOBIS II | Jul 02, 2013 | Substantially Equivalent | SIGNUS MEDIZINTECHNIK GMBH |
| K122957 | TEZO TITANIUM CAGE FAMILY | Jun 21, 2013 | Substantially Equivalent | ULRICH GMBH & CO. KG |
| K131443 | COALIGN INNOVATIONS ACCULIF XL IBF CAGE | Jun 19, 2013 | Substantially Equivalent | COALIGN INNOVATIONS, INC. |
| K130630 | PLATEAU SPACER SYSTEM TITANIUM | Jun 13, 2013 | Substantially Equivalent | LIFE SPINE, INC |
| K124012 | INFILL OBLIQUE TLIF DEVICE | Jun 04, 2013 | Substantially Equivalent | PINNACLE SPINE GROUP, LLC |
| K131216 | RAMPART O | May 30, 2013 | Substantially Equivalent | SPINEOLOGY, INC. |
| K130699 | ALEUTIAN SPINAL SYSTEM | May 30, 2013 | Substantially Equivalent | K2M, INC. |
| K122639 | SYNTHES SYNCAGE EVOLUTION SPACER | May 24, 2013 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC |
| K130506 | IMSE P-TLIF | May 13, 2013 | Substantially Equivalent | INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION |
| K123913 | LATIS SPACER | May 13, 2013 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K130434 | OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC | May 01, 2013 | Substantially Equivalent | EXACTECH, INC. |
| K113781 | PANTHEON SPINAL IBFD SYSTEM | Apr 26, 2013 | Substantially Equivalent | PANTHEON SPINAL |
| K130548 | EPICAGE INTERBODY FUSION DEVICE | Apr 18, 2013 | Substantially Equivalent | ALPHATEC SPINE, INC. |
| K123461 | STAXX(R) IB SYSTEM | Apr 11, 2013 | Substantially Equivalent | SPINE WAVE, INC. |
| K123978 | CAPSTONE L SPINAL SYSTEM | Apr 09, 2013 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA |
| K130194 | ACCULIF XL CAGE | Apr 03, 2013 | Substantially Equivalent | COALIGN INNOVATIONS, INC. |
| K123997 | TRANS1LATERAL INTERBODY FUSION SYSTEM | Apr 01, 2013 | Substantially Equivalent | TRANS1, INC. |
| K123100 | INTESS LUMBAR CAGE | Mar 28, 2013 | Substantially Equivalent | KALITEC DIRECT, LLC |
| K130396 | RAMPART O AND RAMPART P | Mar 25, 2013 | Substantially Equivalent | SPINEOLOGY, INC. |
| K123652 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | Mar 22, 2013 | Substantially Equivalent | SPINEOLOGY, INC. |
| K122037 | ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST | Mar 22, 2013 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K123602 | TM ARDIS INTERBODY SYSTEM INSERTER | Mar 01, 2013 | Substantially Equivalent | ZIMMER TRABECULAR METAL TECHNOLOGY |
| K122967 | LUCENT | Feb 21, 2013 | Substantially Equivalent | SPINAL ELEMENTS, INC. |
| K123969 | XIPHOS | Feb 07, 2013 | Substantially Equivalent | DIFUSION TECHNOLOGIES |
| K123281 | ACCULIF TL-PEEK CAGE | Jan 23, 2013 | Substantially Equivalent | COALIGN INNOVATIONS, INC. |
| K123231 | CALIBER SPACERS | Jan 18, 2013 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K120464 | INNESIS PEEK CAGE | Jan 18, 2013 | Substantially Equivalent | BK MEDITECH CO., LTD. |
| K123752 | ACCULIF TL AND PL CAGE | Jan 14, 2013 | Substantially Equivalent | COALIGN INNOVATIONS, INC. |
| K121254 | CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE | Jan 11, 2013 | Substantially Equivalent | CAMBER SPINE TECHNOLOGIES |
| K123180 | FALCON SPACER | Jan 08, 2013 | Substantially Equivalent | SYNTHES (USA) PRODUCTS LLC |
| K121693 | A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) | Dec 27, 2012 | Substantially Equivalent | SAPPHIRE MEDICAL GROUP, INC |
| K122097 | PATRIOT SPACERS | Dec 06, 2012 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K123207 | PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM | Nov 29, 2012 | Substantially Equivalent | OSTEOMED LP |
| K122956 | FUSELOX LUMBAR INTERBODY FUSION DEVICE | Oct 25, 2012 | Substantially Equivalent | CAPTIVA SPINE |
| K122989 | BIOMET LATERAL SPACER SYSTEM | Oct 24, 2012 | Substantially Equivalent | BIOMET SPINE (AKA EBI, LLC) |
| K122896 | COUGAR LS 15 LATERAL CAGE SYSTEM | Oct 18, 2012 | Substantially Equivalent | MEDOS INTERNATIONAL SARL |
| K121581 | BOX PEEK VBR SYSTEM, | Oct 17, 2012 | Substantially Equivalent | INNOVASIS, INC. |
| K120401 | ALAMO T | Oct 05, 2012 | Substantially Equivalent | ALLIANCE PARTNERS, LLC |
| K121567 | ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM | Sep 26, 2012 | Substantially Equivalent | ACCEL SPINE |
| K122021 | STERISPINE LC CAGE | Sep 20, 2012 | Substantially Equivalent | SAFE ORTHOPAEDICS |
| K122591 | CLYDESDALE SPINAL SYSTEM | Sep 18, 2012 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK, INC. |
| K122047 | ALAMO P | Sep 04, 2012 | Substantially Equivalent | ALLIANCE PARTNERS, LLC |
| K122317 | TETRIS II | Aug 29, 2012 | Substantially Equivalent | SIGNUS MEDIZINTECHNIK GMBH |
| K121760 | CAPSTONE SPINAL SYSTEM | Aug 29, 2012 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K121892 | PHANTOM PLUS CERAMIC CAGE SYSTEM | Aug 24, 2012 | Substantially Equivalent | AMEDICA CORP. |
| K120991 | TRANS1 INTERBODY FUSION SYSTEM | Aug 23, 2012 | Substantially Equivalent | TRANS1 INCORPORATED |
| K121733 | INFILL INTERVERTEBRAL BODY FUSION DEVICE | Jul 13, 2012 | Substantially Equivalent | PINNACLE SPINE GROUP, LLC |
| K121096 | VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM | Jul 06, 2012 | Substantially Equivalent | L & K BIOMED CO., LTD |
| K121683 | ACCULIF TL CAGE | Jul 05, 2012 | Substantially Equivalent | COALIGN INNOVATIONS, INC. |
| K120966 | DEPUY PULSE LUMBAR CAGE SYSTEM | Jul 03, 2012 | Substantially Equivalent | MEDOS INTERNATIONAL SARL |
| K121333 | WAVE D CAGE | Jun 29, 2012 | Substantially Equivalent | ADVANCED MEDICAL TECHNOLOGIES AG |
| K121332 | LOOP CAGE | Jun 29, 2012 | Substantially Equivalent | ADVANCED MEDICAL TECHNOLOGIES AG |
| K121330 | WAVE O CAGE | Jun 29, 2012 | Substantially Equivalent | ADVANCED MEDICAL TECHNOLOGIES AG |
| K121288 | FUSE CAGE | Jun 29, 2012 | Substantially Equivalent | ADVANCED MEDICAL TECHNOLOGIES AG |
| K120918 | NUVASIVE COROENT TITANIUM SYSTEM | Jun 28, 2012 | Substantially Equivalent | NUVASIVE, INC. |
| K121246 | MEDYSSY LT CAGE SYSTEM | Jun 15, 2012 | Substantially Equivalent | MEDYSSEY CO., LTD. |
| K120203 | TM-400 DEVICE | Jun 15, 2012 | Substantially Equivalent | ZIMMER TRABECULAR METAL TECHNOLOGY, INC. |
| K121129 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | Jun 13, 2012 | Substantially Equivalent | SPINEOLOGY, INC. |
| K113561 | TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION | May 29, 2012 | Substantially Equivalent | ZIMMER TRABECULAR METAL TECHNOLOGY |
| K110632 | LUCENT OR LUCENT MAGNUM | May 23, 2012 | Substantially Equivalent | SPINAL ELEMENTS, INC. |
| K121116 | PLATEAU SPACER SYSTEM | May 08, 2012 | Substantially Equivalent | LIFE SPINE |
| K112986 | LATERAL FUSION DEVICE | May 01, 2012 | Substantially Equivalent | INTEGRA SPINE (INTEGRA LIFESCIENCES) |
| K120063 | VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM | Apr 19, 2012 | Substantially Equivalent | L&K BIOMED CO., LTD |
| K112696 | TWIN PEAKS LUMBAR CAGE | Apr 18, 2012 | Substantially Equivalent | QUALGENIX LLC |
| K120368 | CAPSTONE CONTROL SPINAL SYSTEM | Apr 09, 2012 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K120576 | ZAVATION IBF SYSTEM | Mar 28, 2012 | Substantially Equivalent | ZAVATION LLC |
| K112648 | ASFORA BULLET CAGE | Mar 13, 2012 | Substantially Equivalent | MEDICAL DESIGNS, LLC |
| K113540 | RELIANCE LUMBAR IBF SYSTEM | Mar 12, 2012 | Substantially Equivalent | Reliance Medical Systems, LLC |
| K113478 | PLIF CAGE | Mar 05, 2012 | Substantially Equivalent | EISERTECH, LLC |
| K111792 | MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI | Mar 05, 2012 | Substantially Equivalent | SIGNUS MEDIZINTECHNIK GMBH |
| K120293 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE | Feb 29, 2012 | Substantially Equivalent | SPINEOLOGY, INC. |
| K120024 | MECTALIF TRANSFORAMINAL | Feb 28, 2012 | Substantially Equivalent | MEDACTA INTERNATIONAL, SA |
| K113642 | PERIMETER INTERBODY FUSION DEVICE | Feb 06, 2012 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA |
| K111726 | PATHWAY AVID | Feb 06, 2012 | Substantially Equivalent | CUSTOM SPINE, INC. |
| K113447 | RISE SPACER | Jan 26, 2012 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K113030 | SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE | Jan 26, 2012 | Substantially Equivalent | SPINEOLOGY, INC. |
| K113527 | OPTICAGE INTERBODY FUSION DEVICE | Jan 20, 2012 | Substantially Equivalent | INTERVENTIONAL SPINE, INC. |
| K113138 | ALEUTIAN SYSTEM | Jan 10, 2012 | Substantially Equivalent | K2M, INC. |
| K113528 | CLYDESDALE(R) SPINAL SYSTEM | Dec 20, 2011 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K112316 | 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) | Dec 14, 2011 | Substantially Equivalent | 4-WEB, INC. |
| K113348 | COUGAR SYSTEM | Dec 13, 2011 | Substantially Equivalent | JOHNSON & JOHNSON |
| K113465 | ACCULIF TL CAGE | Dec 12, 2011 | Substantially Equivalent | COALIGN INNOVATIONS, INC. |
| K112095 | ACCULIF TL-PEEK IBF CAGE | Dec 01, 2011 | Substantially Equivalent | COALIGN INNOVATIONS, INC. |
| K112405 | CLYDESDALES SPINAL SYSTEM | Nov 21, 2011 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K110562 | TELAMON PEEK SPINAL SYSTEM | Nov 09, 2011 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA |
| K112359 | PROW FUSION | Nov 08, 2011 | Substantially Equivalent | NLT SPINE LTD |
| K111512 | BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM | Oct 26, 2011 | Substantially Equivalent | THOMPSON MIS INC |
| K111965 | VUSION(R) OS | Oct 25, 2011 | Substantially Equivalent | ORTHO DEVELOPMENT |
| K110783 | VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE | Oct 24, 2011 | Substantially Equivalent | L & K BIOMED CO., LTD |
| K112014 | ZYSTON STRAIGHT SPACER SYSTEM | Oct 17, 2011 | Substantially Equivalent | BIOMET SPINE |
| K111354 | GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) | Oct 17, 2011 | Substantially Equivalent | GS MEDICAL CO., LTD. |
| K110694 | CONCORDE BULLET SPINAL SYSTEM | Oct 11, 2011 | Substantially Equivalent | JOHNSON & JOHNSON |
| K112496 | PIONEER CROSSFUSE II IBF/VBR SYSTEM | Sep 28, 2011 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY, INC. |
| K111553 | SPINEFRONTIER LUMBAR IBF SYSTEM | Sep 28, 2011 | Substantially Equivalent | SPINEFRONTIER, INC. |
| K111880 | SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE | Sep 26, 2011 | Substantially Equivalent | Spineology Inc. |
| K110659 | MEDICAL CONCEPTS INTERBODY FUSION SYSTEM | Sep 13, 2011 | Substantially Equivalent | MEDICAL CONCEPTS, INC. |
| K111166 | A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) | Sep 08, 2011 | Substantially Equivalent | SPINEWORKS, LLC |
| K111525 | PERIMETER INTERBODY FUSION DEVICE | Aug 24, 2011 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K110543 | CRESCENT (R) SPINAL SYSTEM TITANIUM | Aug 09, 2011 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K100305 | ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER | Jul 21, 2011 | Substantially Equivalent | ICOTEC |
| K111774 | PATHWAY MODEL 07XXXX | Jul 20, 2011 | Substantially Equivalent | CUSTOM SPINE |
| K103731 | CAPSTONE R SPINAL SYSTEM | Jul 18, 2011 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K111569 | PLATEAU SPACER SYSTEM | Jul 06, 2011 | Substantially Equivalent | LIFE SPINE |
| K110650 | ZYSTON ARC INTERBODY SPACER | Jun 30, 2011 | Substantially Equivalent | BIOMET SPINE (AKA EBI, LLC) |
| K110843 | ALEUTIAN SPACER SYSTEM | Jun 22, 2011 | Substantially Equivalent | K2M, INC. |
| K110933 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | Jun 13, 2011 | Substantially Equivalent | SPINEOLOGY, INC. |
| K110927 | MECTALIF | Jun 13, 2011 | Substantially Equivalent | MEDACTA INTERNATIONAL |
| K110226 | INTERFUSE T INVERTEBRAL BODY FUSION DEVICE | May 27, 2011 | Substantially Equivalent | VERTEBRAL TECHNOLOGIES, INC. |
| K110454 | COUGAR LS LATERAL CAGE SYSTEM | May 13, 2011 | Substantially Equivalent | JOHNSON & JOHNSON |
| K102026 | SEASPINE SPACER SYSTEM | May 12, 2011 | Substantially Equivalent | SEASPINE, INC. |
| K102957 | CUTTING EDGE SPINE INTERBODY FUSION DEVICE | Apr 28, 2011 | Substantially Equivalent | CUTTING EDGE SPINE, LLC |
| K110177 | HELENA SYSTEM | Apr 21, 2011 | Substantially Equivalent | ROYAL OAK MEDICAL DEVICES |
| K103729 | INFILL INTERVERTEBRAL BODY FUSION DEVICE | Apr 18, 2011 | Substantially Equivalent | PINNACLE SPINE GROUP, LLC |
| K110067 | LP CAGE | Apr 08, 2011 | Substantially Equivalent | MEDYSSEY CO., LTD. |
| K110270 | ACCULIF CAGE | Apr 07, 2011 | Substantially Equivalent | COALIGN INNOVATIONS, INC. |
| K103666 | LANX LATERAL | Mar 23, 2011 | Substantially Equivalent | LANX, INC. |
| K103111 | FORZA SPACER SYSTEM | Mar 23, 2011 | Substantially Equivalent | ORTHOFIX INC. |
| K103814 | PEZO INTERBODY CAGES SYSTEM | Mar 17, 2011 | Substantially Equivalent | ULRICH GMBH & CO. KG |
| K103743 | CONCORDE CURVE SYSTEM | Mar 17, 2011 | Substantially Equivalent | JOHNSON & JOHNSON |
| K103488 | CONCORDE BULLET CAGE SYSTEM | Mar 02, 2011 | Substantially Equivalent | JOHNSON AND JOHNSON |
| K100945 | FUSE PLIF CAFE | Feb 09, 2011 | Substantially Equivalent | ADVANCED MEDICAL TECHNOLOGIES AG |
| K110045 | INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE | Feb 03, 2011 | Substantially Equivalent | VERTEBRAL TECHNOLOGIES, INC. |
| K103297 | REDONDO-L | Jan 27, 2011 | Substantially Equivalent | SEASPINE, INC. |
| K083894 | ALIF SPINAL TRUSS INTERBODY FUSION DEVICE | Jan 18, 2011 | Substantially Equivalent | 4-WEB SPINE, LLC |
| K102322 | STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF) | Jan 07, 2011 | Substantially Equivalent | OMNI SURGICAL, L.P. |
| K103228 | PARAMOUNT R IBF DEVICE | Jan 05, 2011 | Substantially Equivalent | THEKEN SPINE LLC |
| K102293 | CALIBER SPACER | Jan 05, 2011 | Substantially Equivalent | GLOBUS MEDICAL INC. |
| K103034 | GENESYS SPINE INTERBODY FUSION SYSTEM | Dec 10, 2010 | Substantially Equivalent | GENESYS SPINE |
| K102313 | PATRIOT TRANSCONTINENTAL M SPACERS | Dec 03, 2010 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K101923 | CONCORDE CURVE SYSTEM | Dec 01, 2010 | Substantially Equivalent | DEPUY SPINE |
| K102067 | ENDOSKELETON TO | Nov 05, 2010 | Substantially Equivalent | TITAN SPINE, LLC |
| K102277 | INTERFUSE T INVERTEBRAL BODY FUSION DEVICE | Oct 06, 2010 | Substantially Equivalent | VERTEBRAL TECHNOLOGIES, INC. |
| K100042 | DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM | Oct 01, 2010 | Substantially Equivalent | DIFUSION TECHNOLOGIES |
| K101301 | STALIF MIDLINE | Sep 24, 2010 | Substantially Equivalent | CENTINEL SPINE |
| K100037 | ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD | Sep 23, 2010 | Substantially Equivalent | ADVANCED VERTEBRAL SOLUTIONS, LLC |
| K100210 | TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T | Aug 26, 2010 | Substantially Equivalent | TRANS1 INCORPORATED |
| K101051 | AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX | Aug 12, 2010 | Substantially Equivalent | STRYKER SPINE |
| K100865 | AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX | Aug 11, 2010 | Substantially Equivalent | STRYKER SPINE |
| K100743 | ATLAS SPINE PIVOTING SYSTEM | Aug 10, 2010 | Substantially Equivalent | ATLAS SPINE INC. |
| K100820 | WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM | Aug 05, 2010 | Substantially Equivalent | WENZEL SPINE |
| K100544 | IMPIX LUMBAR INTERBODY DEVICE | Jul 22, 2010 | Substantially Equivalent | MEDICREA TECHNOLOGIES |
| K101720 | JULIET OL | Jul 16, 2010 | Substantially Equivalent | SPINEART |
| K101085 | SPINESMITH CYNCH SPINAL SYSTEM | Jul 01, 2010 | Substantially Equivalent | SPINE SMITH PARTNERS L.P. |
| K092815 | S-LIF INTERVERTEBRAL BODY FUSION DEVICE | Jun 30, 2010 | Substantially Equivalent | SPINEFRONTIER, INC. |
| K100175 | CLYDESDALE SPINAL SYSTEM | Jun 02, 2010 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K083798 | IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF | May 19, 2010 | Substantially Equivalent | MEDICREA TECHNOLOGIES |
| K100089 | SYNTHES T-PAL SPACER | May 13, 2010 | Substantially Equivalent | SYNTHES SPINE |
| K092901 | EPICAGE INTERBODY FUSION DEVICE | Apr 28, 2010 | Substantially Equivalent | R TREE INNOVATIONS |
| K094025 | CRESCENT SPINAL SYSTEM | Apr 26, 2010 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K093669 | SEC IBF CAGE | Mar 18, 2010 | Substantially Equivalent | INNVOTEC SURGICAL, INC. |
| K093864 | AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX | Mar 11, 2010 | Substantially Equivalent | STRYKER CORP. |
| K093015 | BINDER INTERVERTEBRAL BODY FUSION DEVICE | Feb 25, 2010 | Substantially Equivalent | BINDER BIOMEDICAL, INC |
| K092574 | ESL SPINAL SYSTEM | Feb 04, 2010 | Substantially Equivalent | EBI, L.P. |
| K092774 | ATLAS INTERVERTEBRAL BODY CAGE | Feb 02, 2010 | Substantially Equivalent | SPINAL EDGE, LLC |
| K091278 | VALEO SPACER SYSTEM | Jan 28, 2010 | Substantially Equivalent | AMEDICA CORP. |
| K092162 | 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM | Jan 06, 2010 | Substantially Equivalent | SOLCO BIOMEDICAL CO., LTD. |
| K093704 | AVS PL PEEK SPACERS | Dec 23, 2009 | Substantially Equivalent | STRYKER CORP. |
| K093675 | INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 | Dec 23, 2009 | Substantially Equivalent | VERTEBRAL TECHNOLOGIES, INC. |
| K093242 | PATRIOT TRANSCONTINENTAL LLIF SPACER | Dec 23, 2009 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K092017 | PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) | Dec 01, 2009 | Substantially Equivalent | CAPTIVA SPINE, INC |
| K083626 | DISTRACTABLE WAVE CAGE | Oct 19, 2009 | Substantially Equivalent | ADVANCED MEDICAL TECHNOLOGY, INC. |
| K090353 | PERIMETER INTERBODY FUSION DEVICE | Sep 29, 2009 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K092193 | SPINAL USA INTERBODY CAGES | Sep 25, 2009 | Substantially Equivalent | SPINAL USA |
| K091122 | DIANA FUSION CAGE | Sep 18, 2009 | Substantially Equivalent | SIGNUS MEDICAL |
| K091638 | DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 | Sep 14, 2009 | Substantially Equivalent | SPINEFRONTIER, INC. |
| K090048 | ASFORA BULLET CAGE SYSTEM | Aug 14, 2009 | Substantially Equivalent | MEDICAL DESIGNS, LLC |
| K091381 | IBEX SPINAL SYSTEM | Aug 07, 2009 | Substantially Equivalent | EBI, L.P. |
| K091988 | MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 | Jul 30, 2009 | Substantially Equivalent | VERTEBRAL TECHNOLOGIES, INC. |
| K090707 | TALOS INTERVERTEBRAL BODY FUSION DEVICE | Jul 15, 2009 | Substantially Equivalent | MEDITECH ADVISORS, LLC |
| K090507 | MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM | Jun 25, 2009 | Substantially Equivalent | LDR SPINE USA |
| K090566 | PATHWAY AVID | Jun 01, 2009 | Substantially Equivalent | CUSTOM SPINE, INC. |
| K081917 | DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS | May 22, 2009 | Substantially Equivalent | DEPUY SPINE, INC. |
| K090899 | DEPUY SPINE LATERAL SYSTEM | May 19, 2009 | Substantially Equivalent | DEPUY SPINE, INC. |
| K090425 | GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM | May 19, 2009 | Substantially Equivalent | ALPHATEC SPINE, INC. |
| K090816 | STRYKER SPINE AVS PL PEEK SPACERS | Apr 24, 2009 | Substantially Equivalent | STRYKER CORP. |
| K090782 | NOVEL ALIF SPINAL SPACER SYSTEM | Apr 22, 2009 | Substantially Equivalent | ALPHATEC SPINE, INC. |
| K090166 | AVS ANTERIOR LARGE PEEK SPACERS | Apr 22, 2009 | Substantially Equivalent | STRYKER CORP. |
| K082698 | ALEUTIAN IBF SYSTEM | Apr 21, 2009 | Substantially Equivalent | K2M, INC. |
| K083815 | LANX FUSION SYSTEM | Apr 20, 2009 | Substantially Equivalent | LANX, INC. |
| K083714 | ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) | Apr 15, 2009 | Substantially Equivalent | TITAN SPINE, LLC |
| K090064 | EMINENT SPINE INTERBODY FUSION SYSTEM | Apr 09, 2009 | Substantially Equivalent | EMINENT SPINE |
| K090376 | SPINESMITH CYNCH SPINAL SYSTEM | Apr 01, 2009 | Substantially Equivalent | SPINE SMITH PARTNERS L.P. |
| K083661 | AVS TL PEEK SPACERS | Feb 27, 2009 | Substantially Equivalent | STRYKER CORP. |
| K081888 | DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE | Feb 06, 2009 | Substantially Equivalent | SPINEART |
| K082262 | LDR SPINE ROI INTERBODY FUSION SYSTEM | Feb 02, 2009 | Substantially Equivalent | LDR SPINE USA |
| K082406 | EXPANDABLE PEEK-OPTIMA IMPLANT | Jan 14, 2009 | Substantially Equivalent | EBI, L.P. |
| K082712 | THEKEN SPINE VU EPOD AND VU LPOD SYSTEM | Jan 02, 2009 | Substantially Equivalent | THEKEN SPINE LLC |
| K083026 | CLYDESDALE SPINAL SYSTEM | Dec 29, 2008 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K082128 | DEPUY SPINE LATERAL CAGE SYSTEM | Nov 14, 2008 | Substantially Equivalent | DEPUY SPINE |
| K081673 | DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE | Nov 14, 2008 | Substantially Equivalent | IONICS MEDICAL CORP. |
| K082310 | HOLLYWOOD, PACIFICA, REDONDO, VENTURA | Nov 10, 2008 | Substantially Equivalent | SEASPINE, INC. |
| K082774 | LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | Oct 21, 2008 | Substantially Equivalent | LANX, LLC |
| K082260 | INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES | Oct 17, 2008 | Substantially Equivalent | CALVARY SPINE LLC |
| K082732 | MODIFICATION TO: CAPSTONE SPINAL SYSTEM | Oct 16, 2008 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K081196 | SPINAL USA VBR SYSTEM | Oct 16, 2008 | Substantially Equivalent | SPINAL USA |
| K082270 | OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM | Sep 16, 2008 | Substantially Equivalent | VERTIFLEX, INC. |
| K082342 | MODIFICATION TO CAPSTONE SPINAL SYSTEM | Sep 12, 2008 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K082235 | BLACKSTONE PILLAR XL PEEK SPACERS | Sep 04, 2008 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K081636 | PEEK-OPTIMA ALIF SPACER | Aug 07, 2008 | Substantially Equivalent | BIOMET SPINE |
| K081968 | MODIFICATION TO LUCENT | Aug 05, 2008 | Substantially Equivalent | SPINAL ELEMENTS, INC. |
| K082014 | STRYKER SPINE AVS PL PEEK SPACERS | Jul 28, 2008 | Substantially Equivalent | STRYKER CORP. |
| K081177 | BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM | Jul 23, 2008 | Substantially Equivalent | BLACKSTONE MEDICAL, INC. |
| K080537 | L-VARLOCK | Jun 30, 2008 | Substantially Equivalent | KISCOMEDICA S.A. |
| K080615 | ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) | Jun 17, 2008 | Substantially Equivalent | TITAN SPINE, LLC |
| K080673 | INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE | Jun 10, 2008 | Substantially Equivalent | VERTEBRAL TECHNOLOGIES, INC. |
| K080588 | SCIENT'X TRIBECA VBR | May 30, 2008 | Substantially Equivalent | SCIENT'X USA, INC. |
| K080411 | PLATEAU SPACER SYSTEM | May 15, 2008 | Substantially Equivalent | LIFE SPINE |
| K080314 | SPINAL USA INTERBODY FUSION DEVICE | May 13, 2008 | Substantially Equivalent | SPINAL USA |
| K073177 | PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM | May 13, 2008 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K080401 | SHELL CAGE, WAVE CAGE, LOOP CAGE | May 09, 2008 | Substantially Equivalent | ADVANCED MEDICAL TECHNOLOGIES AG |
| K080281 | PATHWAY | May 01, 2008 | Substantially Equivalent | CUSTOM SPINE, INC. |
| K071983 | AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE | May 01, 2008 | Substantially Equivalent | AESCULAP IMPLANT SYSTEMS, INC. |
| K073440 | FOUNDATION CAGE | Apr 24, 2008 | Substantially Equivalent | CORELINK LLC |
| K073291 | CAPSTONE SPINAL SYSTEM | Apr 24, 2008 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK USA, INC. |
| K080058 | TURBO PRIME IBD SYSTEM | Apr 16, 2008 | Substantially Equivalent | SPINE SELECT, LLC |
| K080083 | INTREPID SPINAL SYSTEM | Apr 10, 2008 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K080758 | AVS PL PEEK SPACERS, MODELS 48351 AND 48353 | Mar 27, 2008 | Substantially Equivalent | STRYKER CORP. |
| K073470 | AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX | Mar 06, 2008 | Substantially Equivalent | STRYKER SPINE |
| K073669 | ORIA NATURA SPACER | Feb 13, 2008 | Substantially Equivalent | CHOICE SPINE, LP |
| K073202 | ARDIS SPACER | Jan 30, 2008 | Substantially Equivalent | ABBOTT SPINE, INC. |
| K073144 | LANX INTERVERTEBRAL BODY FUSION DEVICE | Jan 24, 2008 | Substantially Equivalent | LANX, LLC |
| K072970 | PATRIOT SPACERS | Jan 18, 2008 | Substantially Equivalent | GLOBUS MEDICAL, INC. |
| K073348 | LUCENT MAGNUM | Dec 26, 2007 | Substantially Equivalent | SPINAL ELEMENTS, INC. |
| K072791 | ORACLE SPACER, OPAL SPACER | Dec 26, 2007 | Substantially Equivalent | SYNTHES SPINE |
| K072226 | IMPIX SPACER | Dec 10, 2007 | Substantially Equivalent | MEDICREA TECHNOLOGIES |
| K071795 | NUVASIVE COROENT SYSTEM | Dec 04, 2007 | Substantially Equivalent | NUVASIVE, INC. |
| K071724 | LUCENT | Nov 09, 2007 | Substantially Equivalent | SPINAL ELEMENTS, INC. |
| K072289 | SPINEFRONTIER DORADO VBR | Nov 01, 2007 | Substantially Equivalent | SPINEFRONTIER, INC. |
| K072120 | PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE | Oct 11, 2007 | Substantially Equivalent | INNOVATIVE SPINAL TECHNOLOGIES INC |
FEI Numbers
This FDA classification entry is associated with 422 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 422 registration numbers. Click on an entry to view related FDA registrations.