Product Code: OVD FDA class 2 21 CFR 888.3080

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Orthopedic

The Intervertebral Fusion Device with Integrated Fixation, Lumbar (product code OVD) is an implantable orthopedic device intended to stabilize the lumbar spinal segment to promote fusion, restrict motion, and decrease pain using bone graft with or without supplemental fixation. The device integrates fixation hardware directly into the fusion implant, simplifying lumbar interbody fusion procedures. As an FDA Class 2 device under regulation 888.3080, it requires 510(k) premarket clearance and falls within the Orthopedic specialty. The device is flagged as an implant and is not life-sustaining.

View on FDA

510(k)s

201

FEI Numbers

253

Registration Numbers

253

Unique Applicants

101

Years Active

Basic Information

Product Code: OVD
Device Class: FDA class 2
Regulation Number: 888.3080
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 201 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260810	Anteralign LS coverplate	Jun 10, 2026	Substantially Equivalent	Tyber Medical, LLC
K254202	MectaLIF 3D Metal Anterior	May 05, 2026	Substantially Equivalent	Medacta International S.A.
K253401	SCRIPT Implant System	Apr 29, 2026	Substantially Equivalent	Globus Medical, Inc.
K253559	Ventana A Anterior Lumbar Interbody System	Feb 25, 2026	Substantially Equivalent	Spinal Elements, Inc.
K251829	DeGen Medical Patient Specific Implant (PSI) System	Dec 08, 2025	Substantially Equivalent	Degen Medical
K251575	IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System	Sep 03, 2025	Substantially Equivalent	Alphatec Spine
K250072	CONDUIT SYNFIX Evolution Secured Spacer System	Jul 10, 2025	Substantially Equivalent	Avalign Technologies, Inc.
K251644	ProAM ALIF System	Jun 24, 2025	Substantially Equivalent	Pro Surgical, Inc.
K250845	Curiteva Porous PEEK Standalone ALIF System	Jun 18, 2025	Substantially Equivalent	Curiteva, Inc.
K251459	OneLIF Interbody Fusion System	Jun 12, 2025	Substantially Equivalent	Novapproach Spine, LLC
K243934	Stable-L Lumbar Interbody System	Apr 30, 2025	Substantially Equivalent	Nexus Spine, LLC
K243386	Ventris Intervertebral Body Fusion Device	Apr 22, 2025	Substantially Equivalent	Acuity Surgical Devices, LLC
K250603	AxTiHA® Stand-Alone ALIF System	Mar 24, 2025	Substantially Equivalent	Innovasis
K243802	aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation	Mar 17, 2025	Substantially Equivalent	Carlsmed, Inc.
K243635	aprevo® anterior lumbar interbody fusion device with interfixation	Dec 13, 2024	Substantially Equivalent	Carlsmed, Inc.
K243191	Atlas Spine Lateral Expandable Interbody System	Nov 26, 2024	Substantially Equivalent	Atlas Spine, Inc.
K241077	DeGen Medical Patient Specific Implant (PSI) System	Oct 29, 2024	Substantially Equivalent	Degen Medical
K241992	Catalyft LS Expandable Interbody System	Oct 28, 2024	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K241477	aprevo® anterior lumbar interbody fusion device with interfixation	Oct 09, 2024	Substantially Equivalent	Carlsmed, Inc.
K241487	Interwedge® Standalone Lateral	Oct 02, 2024	Substantially Equivalent	Foundation Surgical Group, Inc.
K241321	Juliet® Ti LL Lumbar Interbody Device	Jul 18, 2024	Substantially Equivalent	Spineart SA
K240368	E3D-A Interbody System	May 15, 2024	Substantially Equivalent	Evolution Spine
K240126	ProAM ALIF System	May 03, 2024	Substantially Equivalent	Pro Surgical, Inc.
K240623	Omnia Medical TiBrid-SA System	Apr 24, 2024	Substantially Equivalent	Omnia Medical, LLC
K233966	Anterior Spine Truss System-Stand Alone (ASTS-SA)	Apr 22, 2024	Substantially Equivalent	4Web Medical, Inc.
K232432	E3D-A Interbody System	Jan 30, 2024	Substantially Equivalent	Evolution Spine
K232123	MectaLIF Anterior Lag Extension	Oct 18, 2023	Substantially Equivalent	Medacta International S.A.
K231486	Stable-L Standalone Lumbar Interbody System	Oct 12, 2023	Substantially Equivalent	Nexus Spine, LLC
K232097	IdentiTi ALIF Interbody Systems	Sep 25, 2023	Substantially Equivalent	Alphatec Spine, Inc.
K232530	Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System	Sep 18, 2023	Substantially Equivalent	Nexus Spine, LLC
K232154	MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation	Sep 11, 2023	Substantially Equivalent	MiRus, LLC
K230894	NuVasive Modulus ALIF System	Jun 16, 2023	Substantially Equivalent	Nu Vasive, Incorporated
K230731	Zavation ALIF System	Jun 14, 2023	Substantially Equivalent	Zavation Medical Products, LLC
K230808	PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System	Apr 21, 2023	Substantially Equivalent	Kyocera Medical Technologies, Inc.
K221324	ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)	Mar 30, 2023	Substantially Equivalent	Camber Spine Technologies
K223413	Pisces-SA STANDALONE ALIF Interbody System	Feb 10, 2023	Substantially Equivalent	Osseus Fusion Systems
K223146	EVOLUTION SPINE Interbody System	Feb 07, 2023	Substantially Equivalent	Evolution Spine
K222554	EL CAPITAN Anterior Lumbar Interbody Fusion	Jan 19, 2023	Substantially Equivalent	Astura Medical
K222009	aprevo® anterior lumbar interbody fusion device with interfixation	Nov 22, 2022	Substantially Equivalent	Carlsmed, Inc.
K221545	MectaLIF Anterior Extension	Oct 24, 2022	Substantially Equivalent	Medacta International S.A.
K221751	NuVasive Cohere ALIF System Intervertebral Body Fusion Device	Oct 21, 2022	Substantially Equivalent	Nu Vasive, Incorporated
K221936	Standalone ALIF Interbody Fusion System	Oct 17, 2022	Substantially Equivalent	Eminent Spine
K221447	Southern Anterior Screw Fixated Cage (SASCA)	Oct 14, 2022	Substantially Equivalent	Southern Medical (Pty) , Ltd.
K222561	Align	Sep 23, 2022	Substantially Equivalent	Acuity Surgical Devices, LLC
K220610	SOLO-L	May 27, 2022	Substantially Equivalent	Aurora Spine, Inc.
K220115	ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System	May 13, 2022	Substantially Equivalent	MiRus, LLC
K213935	PISCES-SA Standalone ALIF Interbody System	May 06, 2022	Substantially Equivalent	Osseus Fusion Systems
K211837	Altus Spine Interbody Standalone Fusion System	Apr 19, 2022	Substantially Equivalent	Altus Partners, LLC
K213118	Dakota ALIF System	Apr 01, 2022	Substantially Equivalent	Precision Spine, Inc.
K214047	EL CAPITAN Anterior Lumbar Interbody Fusion System	Mar 30, 2022	Substantially Equivalent	Astura Medical
K212498	Stable-L Standalone Lumbar Interbody System	Mar 18, 2022	Substantially Equivalent	Nexus Spine, LLC
K212980	Tesera-k ALIF System	Jan 07, 2022	Substantially Equivalent	Kyocera Medical Technologies, Inc.
K212967	AxTiHA Stand-Alone ALIF System	Oct 15, 2021	Substantially Equivalent	Innovasis, Inc.
K210590	Axis Spine Technologies ALIF	Sep 29, 2021	Substantially Equivalent	Axis Spine Technologies, Ltd.
K211769	OneLIF Intervertebral Body Replacement System	Sep 07, 2021	Substantially Equivalent	Novapproach Spine
K201671	A-Link Z	May 04, 2021	Substantially Equivalent	Acuity Surgical Devices, LLC
K203742	IdentiTi ALIF Standalone Interbody System	Apr 09, 2021	Substantially Equivalent	Alphatec Spine, Inc.
K202032	Idys LLIF 3DTi	Apr 01, 2021	Substantially Equivalent	Clariance, Sas
K210271	NuVasive Modulus ALIF System	Mar 01, 2021	Substantially Equivalent	Nu Vasive, Incorporated
K203207	Omnia Medical TiBrid-SA	Dec 23, 2020	Substantially Equivalent	Omnia Medical, LLC
K202230	NEXXT MATRIXX Stand Alone ALIF System	Dec 15, 2020	Substantially Equivalent	Nexxt Spine, LLC
K202190	Oculus-SA Lumbar Cage System	Oct 02, 2020	Substantially Equivalent	Neurostructures
K201585	Monterey AL Interbody System	Aug 10, 2020	Substantially Equivalent	Stryker Corporation
K201087	CORBEL Spacers	Jul 31, 2020	Substantially Equivalent	Globus Medical, Inc.
K200002	Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device	May 29, 2020	Substantially Equivalent	4Web, Inc.
K200352	Axis Spine Technologies ALIF	May 20, 2020	Substantially Equivalent	Axis Spine Technologies, Ltd.
K200541	Hive Stand-alone Anterior Lumbar Interbody System	Apr 28, 2020	Substantially Equivalent	Hd Lifesciences, LLC
K192492	EL CAPITAN Anterior Lumber Interbody System	Apr 21, 2020	Substantially Equivalent	Astura Medical, LLC
K200338	ProLift Lateral Fixated	Apr 17, 2020	Substantially Equivalent	Life Spine, Inc.
K193593	NuVasive 3DP Interfixated ALIF System	Mar 25, 2020	Substantially Equivalent	Nu Vasive, Incorporated
K193320	KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System	Feb 04, 2020	Substantially Equivalent	Kyocera Medical Technologies, Inc.
K192993	SCARLET AL-T	Jan 22, 2020	Substantially Equivalent	Spineart
K191581	Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device	Jan 08, 2020	Substantially Equivalent	Titan Spine, Inc.
K191834	Stand-Alone ALIF Titanium System	Dec 16, 2019	Substantially Equivalent	Life Spine, Inc.
K192168	Idys ALIF ZP 3DTi	Nov 04, 2019	Substantially Equivalent	Clariance, Sas
K190179	SAHARA Stabilization System	Oct 03, 2019	Substantially Equivalent	K2m, Inc.
K192054	Endoskeleton TAS Plate	Aug 29, 2019	Substantially Equivalent	Titan Spine, Inc.
K192047	Rampart One Lumbar Interbody Fusion System	Aug 23, 2019	Substantially Equivalent	Spineology, Inc.
K182139	AXTi Titanium Stand-Alone ALIF System	Jun 21, 2019	Substantially Equivalent	Innovasis, Inc.
K191263	Idys ALIF TiVac	Jun 06, 2019	Substantially Equivalent	Clariance, Sas
K190877	Juliet® Ti LL Lumbar Interbody Device	May 29, 2019	Substantially Equivalent	Spineart
K191091	Rampart One Lumbar Interbody Fusion System	May 23, 2019	Substantially Equivalent	Spineology, Inc.
K183426	MectaLIF Anterior Stand Alone Extension	Mar 15, 2019	Substantially Equivalent	Medacta International S.A.
K181096	Avenue P Cage System	Jan 15, 2019	Substantially Equivalent	Zimmer Biomet Spine, Inc.
K181118	Reliance Lumbar IBF System	Jan 09, 2019	Substantially Equivalent	Reliance Medical Systems
K182007	Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System	Dec 07, 2018	Substantially Equivalent	Renovis Surgical Technologies
K182195	Arco-SA Lumbar Cage System	Nov 09, 2018	Substantially Equivalent	Neurostructures, Inc.
K181818	Scarlet AL-T	Oct 09, 2018	Substantially Equivalent	Spineart
K180215	DYNA-LINK ELITE Stand-Alone Anterior Lumbar System	Sep 13, 2018	Substantially Equivalent	Life Spine, Inc.
K181386	NuVasive Brigade Lateral System	Aug 24, 2018	Substantially Equivalent	Nu Vasive, Incorporated
K180814	CoreLink® M3 Stand-Alone Anterior Lumbar System	Aug 10, 2018	Substantially Equivalent	Corelink, LLC
K180695	FBC 921 (ALIF)	Jul 12, 2018	Substantially Equivalent	Fbc Device Aps
K180502	S128 Anterior Lumbar Interbody Fusion (ALIF) System	Jun 14, 2018	Substantially Equivalent	Renovis Surgical Technologies, Inc.
K180519	HARRIER-SA Lumbar Interbody System	May 16, 2018	Substantially Equivalent	Choicespine, LP
K180002	Rampart One Lumbar Interbody Fusion Device	Apr 25, 2018	Substantially Equivalent	Spineology, Inc.
K173432	ENZA-A Titanium ALIF	Apr 18, 2018	Substantially Equivalent	Camber Spine Technologies
K173606	SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device	Apr 13, 2018	Substantially Equivalent	SeaSpine Orthopedics Corporation
K173082	Arco-SA Lumbar Cage System	Mar 29, 2018	Substantially Equivalent	Neurostructures, Inc.
K172941	CASCADIA Interbody System	Feb 12, 2018	Substantially Equivalent	K2m
K172019	Brisbane ALIF Device, Gladstone ALIF Device	Nov 29, 2017	Substantially Equivalent	Signature Orthopaedics Pty, Ltd.
K172083	Idys ALIF System	Nov 08, 2017	Substantially Equivalent	Clariance, Sas
K172328	SOVEREIGN Spinal System	Nov 02, 2017	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K170157	INDEPENDENCE® Spacers	Sep 25, 2017	Substantially Equivalent	Globus Medical, Inc.
K170855	T-Rex Standalone ALIF	Sep 07, 2017	Substantially Equivalent	Siats, LLC
K171567	IRIX-A Lumbar Integrated Fusion System	Aug 28, 2017	Substantially Equivalent	X-Spine Systems, Inc.
K163670	Rampart One Lumbar Interbody Fusion Device	May 08, 2017	Substantially Equivalent	Spineology, Inc.
K170592	NuVasive BASE Interfixated Titanium System	Apr 26, 2017	Substantially Equivalent	Nu Vasive, Incorporated
K162236	Ax Stand-Alone ALIF System	Apr 20, 2017	Substantially Equivalent	Innovasis, Inc.
K163269	Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device	Apr 13, 2017	Substantially Equivalent	Titan Spine, LLC
K170455	MectaLIF Anterior Stand Alone	Mar 16, 2017	Substantially Equivalent	Medacta International S.A.
K163543	Biomet Fusion System	Feb 28, 2017	Substantially Equivalent	Zimmer Biomet Spine, Inc.
K162680	SOVEREIGN® Spinal System	Dec 14, 2016	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K162351	SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device	Dec 01, 2016	Substantially Equivalent	SeaSpine Orthopedics Corporation
K161993	Leva® Anterior Interbody System	Nov 22, 2016	Substantially Equivalent	Spine Wave, Inc.
K161379	ELSA Spacers	Sep 29, 2016	Substantially Equivalent	Globus Medical, Inc.
K161173	Avenue® T TLIF Cage	Sep 28, 2016	Substantially Equivalent	Ldr Spine USA, Inc.
K161129	PILLAR SA PTC	Sep 08, 2016	Substantially Equivalent	Orthofix, Inc.
K160597	INDEPENDENCE MIS Spacers	Aug 29, 2016	Substantially Equivalent	Globus Medical, Inc.
K160605	MectaLIF Anterior Stand-Alone	Jul 21, 2016	Substantially Equivalent	Medacta International
K161223	TransContinental® M Spacers and InterContinental® Plate-Spacers	Jul 15, 2016	Substantially Equivalent	Globus Medical, Inc.
K153720	ENZA Zero-Profile Anterior Interbody Fusion	May 03, 2016	Substantially Equivalent	Camber Spine Technologies
K160051	NuVasive® Interfixated Interbody System	Apr 20, 2016	Substantially Equivalent	Nu Vasive, Incorporated
K160291	Optimus ALIF System	Feb 18, 2016	Substantially Equivalent	Amendia, Inc.
K151312	VerteLP Interbody Fusion Device	Jan 13, 2016	Substantially Equivalent	Vgi, LLC
K151481	Sahara Stabilization System	Dec 21, 2015	Substantially Equivalent	K2m, Inc.
K152943	NuVasive Foundation-LL System	Dec 01, 2015	Substantially Equivalent	Nu Vasive, Incorporated
K150673	SYNFIX Evolution Secured Spacer System	Aug 21, 2015	Substantially Equivalent	Synthes (USA) Products, LLC
K151214	ALIF Interfixated System	Jun 25, 2015	Substantially Equivalent	Nu Vasive, Incorporated
K142645	Avenue T TLIF Cage	Jun 11, 2015	Substantially Equivalent	Ldr Spine USA, Inc.
K150643	Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti	Jun 08, 2015	Substantially Equivalent	Centinel Spine, Inc.
K142487	Chesapeake Stabilization System	May 07, 2015	Substantially Equivalent	K2m, Inc.
K143228	Ancora LLC Interbody Fusion Device	Feb 26, 2015	Substantially Equivalent	Frontier Medical Devices, Inc.
K142498	MAGNIFY and MAGNIFY-S Spacers	Feb 26, 2015	Substantially Equivalent	Globus Medical, Inc.
K141798	SYPHER SPACER SYSTEM	Feb 19, 2015	Substantially Equivalent	Biogennix, LLC
K143163	AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System	Jan 26, 2015	Substantially Equivalent	Stryker Corporation
K141187	IMPIX ALIF S/A	Jan 15, 2015	Substantially Equivalent	Medicrea International SA
K142271	Zavation Z-Link Lumbar	Dec 19, 2014	Substantially Equivalent	Zavation, LLC
K133827	A-LINK Z	Nov 17, 2014	Substantially Equivalent	Osteo Vasive, LLC
K142066	AERO-LL LUMBAR CAGE SYSTEM	Nov 13, 2014	Substantially Equivalent	Stryker Corporation
K141942	MIDLINE II TI	Nov 07, 2014	Substantially Equivalent	Centinel Spine, Inc.
K142095	RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM	Oct 15, 2014	Substantially Equivalent	Renovis Surgical Technologies, Inc.
K141791	BIOMET FUSION SYSTEM	Oct 09, 2014	Substantially Equivalent	Biomet Spine
K133947	IRIX-A LUMBAR INTEGRATED FUSION SYSTEM	Jul 29, 2014	Substantially Equivalent	X-Spine Systems, Inc.
K140479	COROENT XL-F SYSTEM	Jul 28, 2014	Substantially Equivalent	Nu Vasive, Incorporated
K133494	CHESAPEAKE SPINAL SYSTEM	Jun 10, 2014	Substantially Equivalent	K2m, Inc.
K133328	AERO-AL LUMBAR CAGE SYSTEM	May 30, 2014	Substantially Equivalent	Stryker Corporation
K132596	PROPOSED OPTIMUS	Apr 11, 2014	Substantially Equivalent	Custom Spine, Inc.
K140106	S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM	Mar 27, 2014	Substantially Equivalent	Renovis Surgical Technologies, Inc.
K133286	MIDLINE (TM)	Jan 09, 2014	Substantially Equivalent	Centinel Spine, Inc.
K131276	LATERAL SYNFIX	Jan 06, 2014	Substantially Equivalent	Synthes (USA) Products, LLC
K132559	MONUMENT SPACERS	Dec 30, 2013	Substantially Equivalent	Globus Medical, Inc.
K131723	COROENT SINGLE TAB SYSTEM	Sep 20, 2013	Substantially Equivalent	Nuvasive, Inc.
K131122	S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM	Sep 18, 2013	Substantially Equivalent	Renovis Surgical Technologies, LLC
K130641	LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE	Sep 13, 2013	Substantially Equivalent	Binder Biomedical, Inc.
K130461	STALIF X	Aug 28, 2013	Substantially Equivalent	Centinel Spine, Inc.
K131547	LANX FUSION SYSTEM	Jul 12, 2013	Substantially Equivalent	Lanx, Inc.
K124034	MECTALIF ANTERIOR	May 17, 2013	Substantially Equivalent	Medacta International
K130445	VAULT ALIF SYSTEM	Apr 25, 2013	Substantially Equivalent	Spinal USA
K123045	BRIGADE STANDALONE SYSTEM	Apr 16, 2013	Substantially Equivalent	Nuvasive, Inc.
K123767	LANX FUSION SYSTEM- SA	Mar 18, 2013	Substantially Equivalent	Lanx, Inc.
K123993	SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM	Mar 05, 2013	Substantially Equivalent	Alphatec Spine, Inc.
K112700	FRONTIER SADL INTERBODY FUSION DEVICE	Nov 01, 2012	Substantially Equivalent	Frontier Medical Devices, Inc.
K120869	ANCHOR-L LUMBAR CAGE	Oct 25, 2012	Substantially Equivalent	Stryker Spine
K122168	VISUALIF CHALLENGING ACCESS PLATE	Oct 11, 2012	Substantially Equivalent	Spine Smith Partners L.P.
K121982	SOVEREIGN SPINAL SYSTEM	Jul 26, 2012	Substantially Equivalent	Medtronic Sofamor Danek
K113285	LDR SPINE USA AVENUE L INTERBODY FUSION	Jul 26, 2012	Substantially Equivalent	Ldr Spine USA, Inc.
K121211	VU APOD INTERVERTEBRAL BODY FUSION DEVICE	Jun 27, 2012	Substantially Equivalent	Theken Spine, LLC
K120101	INDEPENDENCE SPACER	Mar 27, 2012	Substantially Equivalent	Globus Medical, Inc.
K120557	SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35	Mar 19, 2012	Substantially Equivalent	Biomet Spine & Bone Healing Technologies
K120031	CHESAPEAKE SPINAL SYSTEM	Mar 16, 2012	Substantially Equivalent	K2m, Inc.
K112561	NUVASIVE COROENT NO-PROFILE SYSTEM	Mar 13, 2012	Substantially Equivalent	Nuvasive, Inc.
K110063	SOVEREIGN SPINAL SYSTEM	Oct 04, 2011	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K110327	LDR SPINE ROI-A INTERBODY FUSION SYSTEM	Sep 30, 2011	Substantially Equivalent	Ldr Spine USA
K111626	ENDOSKELETON(R) TAS	Sep 09, 2011	Substantially Equivalent	Titan Spine, LLC
K111122	AESCULAP SIBD XP SPINAL SYSTEM	Aug 04, 2011	Substantially Equivalent	Aesculap Implant Systems, Inc.
K103382	INTERCONTINENTAL PLATE-SPACER	May 20, 2011	Substantially Equivalent	Globus Medical, Inc.
K103369	VAULT ALIF SYSTEM	Apr 04, 2011	Substantially Equivalent	Spinal USA
K102402	SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM	Mar 30, 2011	Substantially Equivalent	Alphatec Spine, Inc.
K102738	LANX FUSION SYSTEM	Feb 10, 2011	Substantially Equivalent	Lanx, LLC
K102121	ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR	Jan 12, 2011	Substantially Equivalent	Apollo Spine, Inc.
K100516	ANYPLUS PEEK CAGES	Dec 03, 2010	Substantially Equivalent	GS Medical Co., Ltd.
K102090	SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM	Sep 30, 2010	Substantially Equivalent	Spine Smith Partners L.P.
K101310	VU APOD INTERVERTEBRAL BODY FUSION DEVICE	Sep 02, 2010	Substantially Equivalent	Theken Spine, LLC
K100802	AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM	Jul 20, 2010	Substantially Equivalent	Aesculap Implant Systems, Inc.
K100043	COROENT XLR STANDALONE SYSTEM	Jun 16, 2010	Substantially Equivalent	Nuvasive, Inc.
K093808	INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE	Mar 24, 2010	Substantially Equivalent	Incite Innovation, LLC
K093629	SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM	Mar 09, 2010	Substantially Equivalent	Biomet Spine
K092211	CHESAPEAKE SPINAL SYSTEM	Mar 05, 2010	Substantially Equivalent	K2m, Inc.
K091301	LIFE SPINE STAND-ALONE SPACER SYSTEM	Dec 15, 2009	Substantially Equivalent	Life Spine
K091813	INTREPID SPINAL SYSTEM	Nov 17, 2009	Substantially Equivalent	Medtronic Sofamor Danek
K083475	LUCENT MAGNUM	Feb 13, 2009	Substantially Equivalent	Spinal Elements, Inc.
K082926	ZUMA, MODEL 55-XXXX/56-XXXX	Dec 22, 2008	Substantially Equivalent	Seaspine, Inc.
K082252	INDEPENDENCE SPACER	Nov 05, 2008	Substantially Equivalent	Globus Medical, Inc.
K081711	LUCENT MAGNUM+	Sep 11, 2008	Substantially Equivalent	Spinal Elements, Inc.
K081849	BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE	Aug 28, 2008	Substantially Equivalent	Blackstone Medical, Inc.
K081501	SOLITAIRE ANTERIOR SPINAL SYSTEM	Jul 02, 2008	Substantially Equivalent	Biomet Spine
K080822	VU APOD INTERVERTABRAL BODY FUSION DEVICE	Jul 02, 2008	Substantially Equivalent	Theken Spine, LLC
K081395	SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM	Jun 25, 2008	Substantially Equivalent	Biomet Spine
K073109	STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM	Jun 04, 2008	Substantially Equivalent	Surgicraft , Ltd.
K072253	SYNFIX-LR SPACER	Oct 12, 2007	Substantially Equivalent	Synthes Spine Co.Lp
K071922	INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC	Sep 18, 2007	Substantially Equivalent	Rsb Spine, LLC