Product Code: MQP FDA class 2 21 CFR 888.3060

Spinal Vertebral Body Replacement Device

Orthopedic

The Spinal Vertebral Body Replacement Device is an orthopedic implant used to replace one or more vertebral bodies following trauma, tumor resection, or infection, restoring spinal column height and stability. Classified as FDA Class 2 under 21 CFR 888.3060 in the Orthopedic specialty, it requires 510(k) premarket notification. The product code is MQP, and it carries an implant flag.

View on FDA

510(k)s

277

FEI Numbers

222

Registration Numbers

222

Unique Applicants

106

Years Active

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Basic Information

Product Code: MQP
Device Class: FDA class 2
Regulation Number: 888.3060
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 277 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253158	VyBrate VBR System	Jan 07, 2026	Substantially Equivalent	Vy Spine, LLC
K241468	Vertiwedge® Intraosseous System	Nov 07, 2024	Substantially Equivalent	Foundation Surgical Group, Inc.
K232790	KONG®-TL VBR System and KONG® C VBR System	Apr 04, 2024	Substantially Equivalent	Icotec AG
K233359	DOMINION Expandable Corpectomy System	Mar 08, 2024	Substantially Equivalent	Astura Medical
K231134	VerteLoc Spinal System	Feb 13, 2024	Substantially Equivalent	Signature Orthopaedics Pty, Ltd.
K232173	Ascend VBR System, Ascend NanoTec VBR System	Oct 06, 2023	Substantially Equivalent	Alphatec Spine, Inc.
K211892	ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)	Oct 06, 2022	Substantially Equivalent	Arftx Medical, LLC
K202637	F3D Corpectomy System	Dec 23, 2020	Substantially Equivalent	Corelink, LLC
K200235	KONG-TL VBR System, KONG-C VBR System	May 29, 2020	Substantially Equivalent	Icotec AG
K193506	NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System	Feb 26, 2020	Substantially Equivalent	Nu Vasive, Incorporated
K192117	Small VBR	Nov 01, 2019	Substantially Equivalent	Ulrich GmbH & Co. KG
K190349	MediExpand TL Expandable VBR System	Oct 24, 2019	Substantially Equivalent	Cmf Medicon Surgical, Inc.
K192214	CarboClear VBR System	Oct 11, 2019	Substantially Equivalent	CarboFix Orthopedics , Ltd.
K183054	SYNMESH System	May 23, 2019	Substantially Equivalent	Depuy Synthes Spine
K190147	COLOSSEUM Mesh	May 08, 2019	Substantially Equivalent	Globus Medical, Inc.
K183197	PYRAMESH Implant System	Apr 04, 2019	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K183588	Choice Spine Hawkeye Vertebral Body Replacement (VBR) System	Feb 22, 2019	Substantially Equivalent	Choicespine
K183510	T2 STRATOSPHERE Expandable Corpectomy System	Jan 16, 2019	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K180665	SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System	Nov 28, 2018	Substantially Equivalent	K2m, LLC
K181921	Solidity Vertebral Body Replacement	Nov 16, 2018	Substantially Equivalent	Ulrich Medical USA
K181328	T2 STRATOSPHERE Expandable Corpectomy System	Sep 19, 2018	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K173982	FORTIFY Corpectomy Spacers	Sep 19, 2018	Substantially Equivalent	Globus Medical, Inc.
K173787	X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System	Jun 11, 2018	Substantially Equivalent	Medos International SARL
K173800	Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage	Feb 02, 2018	Substantially Equivalent	Camber Spine Technologies
K172330	Blustone Synergy Silica System	Dec 21, 2017	Substantially Equivalent	Blustone Synergy
K173125	T2 STRATOSPHERE Expandable Corpectomy System	Dec 20, 2017	Substantially Equivalent	Medtronic Sofamor Danek
K162315	FORTIFY Corpectomy Spacers	Nov 09, 2017	Substantially Equivalent	Globus Medical, Inc.
K172323	Omnia Medical VBR	Oct 26, 2017	Substantially Equivalent	Omnia Medical, LLC
K171686	Choice Spine Hawkeye Vertebral Body Replacement (VBR) System	Sep 15, 2017	Substantially Equivalent	Choicespine
K171704	CAPRI Corpectomy Cage System	Aug 31, 2017	Substantially Equivalent	K2m
K162133	VerteFIT Corpectomy Cage System	May 16, 2017	Substantially Equivalent	Ldr Spine USA, Inc.
K170055	CAPRI Corpectomy Cage System	Apr 13, 2017	Substantially Equivalent	K2m
K170271	NuVasive(r) Monolith Corpectomy System	Mar 30, 2017	Substantially Equivalent	Nu Vasive, Incorporated
K152460	Rectangular Corpectomy Cage	Dec 22, 2015	Substantially Equivalent	Amendia, Inc.
K151538	NuVasive PEEK Corpectomy Railed System	Sep 04, 2015	Substantially Equivalent	Nu Vasive, Incorporated
K151167	NuVasive PEEK Corpectomy System	Sep 03, 2015	Substantially Equivalent	Nu Vasive, Incorporated
K142005	SpineFab Vertebral Body Replacement (VBR) System	Jul 10, 2015	Substantially Equivalent	Oxford Performance Materials
K142205	NuVasive X-CORE(R) Expandable VBR System	Feb 20, 2015	Substantially Equivalent	Nuvasive, Inc.
K142996	StaXx(R) XD System	Feb 19, 2015	Substantially Equivalent	Spine Wave, Inc.
K143490	VERTA Corpectomy Cage	Jan 26, 2015	Substantially Equivalent	Camber Spine
K142030	STGC-LORDOTIC	Jan 23, 2015	Substantially Equivalent	Cardinal Spine, LLC
K142016	CAPRI	Nov 06, 2014	Substantially Equivalent	K2m, Inc.
K142150	AIS MODULIFT VBR SYSTEM	Oct 29, 2014	Substantially Equivalent	Aesculap Implant System, Inc.
K140563	LATERAL VBR SYSTEM	Aug 07, 2014	Substantially Equivalent	Nu Vasive, Incorporated
K133802	AIS MODULIFT VBR SYSTEM	Apr 17, 2014	Substantially Equivalent	Aesculap Implant System, Inc.
K123758	TASMIN R	Jan 14, 2014	Substantially Equivalent	Signus Medizintechnik GmbH
K131724	PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE	Dec 24, 2013	Substantially Equivalent	Pioneer Surgical Technology, Inc.
K133207	STAXX(R) SYSTEM	Dec 06, 2013	Substantially Equivalent	Spine Wave, Inc.
K131888	T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE	Sep 23, 2013	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K122622	ENDURAMESH	Sep 19, 2012	Substantially Equivalent	Lucero Medical, LLC
K121889	STAXX XD SYSTEM	Aug 29, 2012	Substantially Equivalent	Spine Wave, Inc.
K121176	STGC	Aug 17, 2012	Substantially Equivalent	Cardinal Spine, LLC
K121107	FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)	Jul 03, 2012	Substantially Equivalent	Globus Medical, Inc.
K120570	CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM	Apr 05, 2012	Substantially Equivalent	Choicespine, LP
K111294	SANTORINI SPINAL SYSTEM	Jan 27, 2012	Substantially Equivalent	K2m, Inc.
K112429	GIZA(R) VERTEBRAL BODY REPLACEMENT	Jan 26, 2012	Substantially Equivalent	Eden Spine, LLC
K111418	STAXX(R) XD SYSTEM	Dec 13, 2011	Substantially Equivalent	Spine Wave, Inc.
K103320	SYNTHES XRL	Oct 20, 2011	Substantially Equivalent	Synthes Spine Co.Lp
K110153	SFC VERTEBRAL BODY REPLACEMENT	Oct 12, 2011	Substantially Equivalent	Konigsee Implantate GmbH
K112756	FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS	Oct 07, 2011	Substantially Equivalent	Globus Medical, Inc.
K102315	STAXX XDL SYSTEM	Aug 19, 2011	Substantially Equivalent	Spine Wave, Inc.
K101886	DSC/ALF SPINAL SYSTEM	Jul 21, 2011	Substantially Equivalent	Sintea Plastek, LLC
K111469	STAXXSD SYSTEM	Jul 19, 2011	Substantially Equivalent	Spine Wave, Inc.
K110864	BIOSPINE VBR SYSTEM	Jun 15, 2011	Substantially Equivalent	Aesculap Implant Systems, LLC
K102682	STAXX(R) XD SYSTEM	Nov 30, 2010	Substantially Equivalent	Spine Wave, Inc.
K100976	T2 XVBR 1.5 SPINAL SYSTEM	Oct 21, 2010	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K101288	STAXX XD SYSTEM	Sep 10, 2010	Substantially Equivalent	Spine Wave, Inc.
K093207	ENDURAMESH, MODEL 762.XXX	Apr 26, 2010	Substantially Equivalent	Lucero Medical, LLC
K093127	TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET	Mar 04, 2010	Substantially Equivalent	Zimmer Trabecular Metal Technology
K083186	AESCULAP HYDROLIFT VBR SYSTEM	Mar 04, 2010	Substantially Equivalent	Aesculap Implant System, Inc.
K091426	CERVICORE CORPECTOMY CAGE	Dec 23, 2009	Substantially Equivalent	Verticor, Ltd.
K091743	SEC VBR	Nov 02, 2009	Substantially Equivalent	Innvotec Surgical, Inc.
K092336	C-THRU SPINAL SYSTEM	Oct 15, 2009	Substantially Equivalent	Ebi, L.P.
K090841	ADDPLUS	Oct 05, 2009	Substantially Equivalent	Ulrich GmbH & Co. KG
K091946	VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX	Sep 25, 2009	Substantially Equivalent	Stryker Spine
K091883	T2 SPINAL SYSTEM	Sep 21, 2009	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K091406	ATLAS SPINE SPACER	Sep 04, 2009	Substantially Equivalent	Atlas Spine, LLC
K090315	STAXX XD SYSTEM	Sep 03, 2009	Substantially Equivalent	Spine Wave, Inc.
K090176	NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM	Apr 27, 2009	Substantially Equivalent	Nuvasive, Inc.
K083857	LDR SPINE ROI-C IMPLANT	Feb 12, 2009	Substantially Equivalent	Ldr Spine USA
K082466	XYCOR SPINAL IMPLANT	Jan 09, 2009	Substantially Equivalent	Vertebration,Inc
K082112	T2 XVBR SPINAL SYSTEM	Aug 27, 2008	Substantially Equivalent	Medtronic Sofamor Danek
K081383	RELIANCE VBS SYSTEM	Jul 02, 2008	Substantially Equivalent	Reliance Medical Systems, LLC
K080971	SPINESMITH CIMPLICITY SPINAL SYSTEM	Jul 02, 2008	Substantially Equivalent	Spine Smith Partners L.P.
K081564	CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION	Jun 30, 2008	Substantially Equivalent	Creaspine
K072326	OSTAPEK VBR SYSTEM	Jun 24, 2008	Substantially Equivalent	Co-Ligne AG
K081332	ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM	Jun 10, 2008	Substantially Equivalent	Signus Medizintechnik GmbH
K080860	CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM	May 29, 2008	Substantially Equivalent	Creaspine
K080728	LDR SPINE ROI-C IMPLANT	May 29, 2008	Substantially Equivalent	Ldr Spine USA
K080699	NOVEL SPINAL SPACER SYSTEM	May 21, 2008	Substantially Equivalent	Alphatec Spine, Inc.
K080569	LDR SPINE ROI-T IMPLANT	May 07, 2008	Substantially Equivalent	Ldr Spine USA
K080568	X-MESH EXPANDABLE CAGE SYSTEM	May 01, 2008	Substantially Equivalent	Depuy Spine, Inc.
K080572	LDR SPINE ROI-A IMPLANT	Apr 07, 2008	Substantially Equivalent	Ldr Spine USA
K073502	VERTEBRON VBR SYSTEM	Mar 24, 2008	Substantially Equivalent	Vertebron, Inc.
K080349	KIMBA MINI	Mar 10, 2008	Substantially Equivalent	Signus Medizintechnik GmbH
K073649	BENGAL STACKABLE CAGE SYSTEM	Jan 25, 2008	Substantially Equivalent	Depuy Spine, Inc.
K080024	ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01	Jan 24, 2008	Substantially Equivalent	K2m, Inc.
K073505	MODIFICATION TO VALEO VBR	Jan 09, 2008	Substantially Equivalent	Amedica Corp.
K072537	CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM	Dec 18, 2007	Substantially Equivalent	Creaspine Sas
K073125	VALEO VBR	Dec 05, 2007	Substantially Equivalent	Amedica Corp.
K071726	ZUMA	Oct 23, 2007	Substantially Equivalent	Seaspine, Inc.
K072029	PHENIX VERTEBRAL BODY REPLACEMENT	Oct 15, 2007	Substantially Equivalent	New Business Development, LLC
K072465	NIKO CORPECTOMY SPACER	Oct 04, 2007	Substantially Equivalent	Globus Medical, Inc.
K063637	RELIANCE VBS SYSTEM	Sep 27, 2007	Substantially Equivalent	Reliance Medical Systems, LLC
K070754	TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155	Aug 31, 2007	Substantially Equivalent	Zimmer Trabecular Metal Technology
K072132	LDR SPINE ROI-T SYSTEM	Aug 30, 2007	Substantially Equivalent	Ldr Spine USA
K071274	GSO GS1 SPACER	Aug 24, 2007	Substantially Equivalent	Gold Standard Orthopedics, LLC
K071033	T2 XVBR SPINAL SYSTEM	Aug 14, 2007	Substantially Equivalent	Medtronic Sofamor Danek
K071031	VU E*POD VERTEBRAL BODY REPLACEMENT	Jul 30, 2007	Substantially Equivalent	Theken Spine, LLC
K071497	ATLAS SPINE VERTEBRAL BODY REPLACEMENT	Jun 29, 2007	Substantially Equivalent	Atlas Spine, Inc.
K070786	X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT	Jun 28, 2007	Substantially Equivalent	Theken Spine, LLC
K063393	SMALL STATURE SPACERS	Jun 25, 2007	Substantially Equivalent	Biomet Spine
K071372	MODIFICATION TO: INTERPLATE VBR SYSTEM	Jun 11, 2007	Substantially Equivalent	Rsb Spine, LLC
K070382	VISTA -S DEVICE	May 30, 2007	Substantially Equivalent	Zimmer Trabecular Metal Technology
K070381	THEKEN VU MESH VBR SYSTEM	Apr 25, 2007	Substantially Equivalent	Theken Spine, LLC
K070082	XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY	Apr 20, 2007	Substantially Equivalent	Vertebration,Inc
K070316	INTERPLATE VBR SYSTEM	Apr 19, 2007	Substantially Equivalent	Rsb Spine, LLC
K070181	SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX	Apr 18, 2007	Substantially Equivalent	Sintea Biotech, Inc.
K070218	VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)	Apr 06, 2007	Substantially Equivalent	Vertiflex (Tm), Incorporated
K062083	SYNFIX -LR	Apr 03, 2007	Substantially Equivalent	Synthes Spine Co.Lp
K070173	VERTE-STACK SPINAL SYSTEM	Mar 14, 2007	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K063464	ATLAS SPINE VERTEBRAL BODY REPLACEMENT	Mar 09, 2007	Substantially Equivalent	Atlas Spine, Inc.
K063491	T2 SCEPTOR SPINAL SYSTEM	Mar 05, 2007	Substantially Equivalent	Medtronic Sofamor Danek
K063205	ATLAS SPINE VERTEBRAL BODY REPLACEMENT	Feb 26, 2007	Substantially Equivalent	Atlas Spine, LLC
K063399	ALEUTIAN SPACER SYSTEM	Feb 23, 2007	Substantially Equivalent	K2m, Inc.
K062933	SYNTHES ORACLE SPACER	Jan 31, 2007	Substantially Equivalent	Synthes Spine Co.Lp
K062666	VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS	Jan 25, 2007	Substantially Equivalent	Ortho Development Corp.
K062759	PARAMOUNT VBR SYSTEM	Jan 12, 2007	Substantially Equivalent	Innovative Spinal Technologies, Inc.
K061578	SSP VERTEBRAL BODY REPLACEMENT	Dec 26, 2006	Substantially Equivalent	Specialty Spine Products, LLC
K060416	OBELISC VERTEBRAL BODY REPLACEMENT DEVICE	Dec 26, 2006	Substantially Equivalent	Ulrich GmbH & Co. KG
K062151	BOX PEEK VBR SYSTEM	Dec 22, 2006	Substantially Equivalent	Innovasis, Inc.
K061082	MOBIS SPINAL IMPLANT	Dec 18, 2006	Substantially Equivalent	Signus Medizintechnik GmbH
K062810	SOLITAIRE ANTERIOR SPINAL SYSTEM	Oct 17, 2006	Substantially Equivalent	Ebi, L.P.
K062133	MODIFICATION TO VERTE-STACK SPINAL SYSTEM	Sep 26, 2006	Substantially Equivalent	Medtronic Spinal and Biologics Div
K061155	VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM	Sep 22, 2006	Substantially Equivalent	Zimmer Trabecular
K060762	AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM	Sep 14, 2006	Substantially Equivalent	Aesculap, Inc.
K062427	VERTE-STACK SPINAL SYSTEM	Sep 12, 2006	Substantially Equivalent	Medtronic Sofamor Danek
K061891	SYNEX II	Aug 18, 2006	Substantially Equivalent	Synthes Spine Co.Lp
K061401	INTERPLATE VBR SYSTEM	Aug 18, 2006	Substantially Equivalent	Rsb Spine, LLC
K062132	AVS PL PEEK SPACER SYSTEM	Aug 16, 2006	Substantially Equivalent	Stryker Spine
K062004	MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT	Aug 15, 2006	Substantially Equivalent	Quantum Orthopedics, Inc.
K061752	SPINAL USA VBR SYSTEM	Aug 15, 2006	Substantially Equivalent	Spinal USA
K062073	VERTE-STACK SPINAL SYSTEM	Aug 14, 2006	Substantially Equivalent	Medtronic Sofamor Danek
K061938	VERTE-STACK SPINAL SYSTEM	Aug 09, 2006	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K061836	AVS ASL PEEK SPACER SYSTEM	Aug 03, 2006	Substantially Equivalent	Stryker Spine
K061151	PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)	Jul 24, 2006	Substantially Equivalent	Pioneer Surgical Technology
K061576	MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM	Jul 03, 2006	Substantially Equivalent	Quantum Orthopedics, Inc.
K061380	RETAIN RADIOLUCENT SPACER	Jun 08, 2006	Substantially Equivalent	Globus Medical, Inc.
K061016	EBI ESL PEEK-OPTIMA SPINE SYSTEM	Jun 08, 2006	Substantially Equivalent	Ebi, L.P.
K060916	ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.	Jun 08, 2006	Substantially Equivalent	Spinal Edge, LLC
K060506	STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM	May 25, 2006	Substantially Equivalent	Stryker Spine
K060665	XPAND RADIOLUCENT CORPECTOMY SPACER	May 10, 2006	Substantially Equivalent	Globus Medical, Inc.
K052670	STAXX XD SYSTEM	Apr 27, 2006	Substantially Equivalent	Spine Wave, Inc.
K060719	MODIFICATION TO VERTE-STACK SPINAL SYSTEM	Apr 14, 2006	Substantially Equivalent	Medtronic Sofamor Danek
K052641	MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT	Apr 12, 2006	Substantially Equivalent	Quantum Orthopedics, Inc.
K060350	CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM	Feb 24, 2006	Substantially Equivalent	Blackstone Medical, Inc.
K051525	ARX SPINAL SYSTEM	Feb 17, 2006	Substantially Equivalent	Amedica Corp.
K053508	SYNFIX-LR	Feb 13, 2006	Substantially Equivalent	Synthes Spine Co.Lp
K053292	DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS	Jan 19, 2006	Substantially Equivalent	Scient'X USA, Inc.
K052170	SEASPINE VBR SYSTEM	Dec 21, 2005	Substantially Equivalent	Seaspine, Inc.
K051781	GRAFTCAGE TLX	Dec 16, 2005	Substantially Equivalent	Osteotech, Inc.
K052210	NUVASIVE COROENT EXTENSURE SYSTEM	Dec 12, 2005	Substantially Equivalent	Nuvasive, Inc.
K053080	GRAFTCAGE ACX	Dec 01, 2005	Substantially Equivalent	Osteotech, Inc.
K052950	THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM	Nov 16, 2005	Substantially Equivalent	Zimmer Trabecular
K052931	MODIFICATION TO VERTE-STACK SPINAL SYSTEM	Nov 16, 2005	Substantially Equivalent	Medtronic Sofamor Danek
K051205	STRYKER SPINE AVS ASL PEEK SPACER	Nov 04, 2005	Substantially Equivalent	Stryker Spine
K052533	KIMBA SPINAL IMPLANT	Nov 03, 2005	Substantially Equivalent	Signus Medizintechnik GmbH
K052746	CONCORDE VBR SPINAL SYSTEM	Oct 21, 2005	Substantially Equivalent	Depuy Spine, Inc.
K052384	LANX VBR SYSTEM	Oct 07, 2005	Substantially Equivalent	Lanx, LLC
K052261	MODIFICATION TO: VERTE-STACK SPINAL SYSTEM	Oct 07, 2005	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K050997	EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE	Oct 07, 2005	Substantially Equivalent	Flexuspine, Inc.
K051978	TRABECULAR METAL VERTEBRAL BODY REPLACEMENT	Sep 23, 2005	Substantially Equivalent	Implex Corp.
K052096	NUBIC SPINAL IMPLANT	Aug 16, 2005	Substantially Equivalent	Signus Medical, LLC
K051454	ALEUTIAN SPACER SYSTEM	Jul 27, 2005	Substantially Equivalent	K2m, LLC
K051659	SEMIAL SPINAL IMPLANT	Jul 13, 2005	Substantially Equivalent	Signus Medizintechnik GmbH
K050449	QUANTUM VERTEBRAL BODY REPLACEMENT	Jul 07, 2005	Substantially Equivalent	Quantum Orthopedics, Inc.
K043479	MC+ PARTIAL VBR	Jun 30, 2005	Substantially Equivalent	Ldr Spine USA
K051027	STALIF TT	Jun 29, 2005	Substantially Equivalent	Surgicraft , Ltd.
K043349	OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)	Jun 29, 2005	Substantially Equivalent	Ldr Spine USA
K051196	TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1	Jun 17, 2005	Substantially Equivalent	Implex Corp.
K051246	CONSTRUX MINI PEEK VBR SYSTEM	Jun 14, 2005	Substantially Equivalent	Blackstone Medical, Inc.
K051105	BASIS VERTEBRAL BODY SPACER	Jun 09, 2005	Substantially Equivalent	Medtronic Sofamor Danek
K050861	PEEK CAS	May 27, 2005	Substantially Equivalent	Interpore Cross Intl.
K050348	CO VERTEBRAL BODY REPLACEMENT	May 27, 2005	Substantially Equivalent	Scient'X
K050850	XPAND CORPECTOMY SPACER	May 26, 2005	Substantially Equivalent	Globus Medical, Inc.
K051000	FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE	May 19, 2005	Substantially Equivalent	Spinal Concepts, Inc.
K050058	THEKEN REVEAL VBR SYSTEM	May 17, 2005	Substantially Equivalent	Theken Surgical,Llc
K050553	NOVEL VBR SPINAL SYSTEM	Apr 18, 2005	Substantially Equivalent	Alphatec/Nexmed
K050624	STRYKER SPINE AVS PL PEEK SPACER	Apr 11, 2005	Substantially Equivalent	Stryker Spine
K042600	STANSION MATRIX	Feb 18, 2005	Substantially Equivalent	Spineworks, LLC
K042571	STRYKER SPINE AVS TL PEEK SPACER	Feb 11, 2005	Substantially Equivalent	Stryker Spine
K043405	NUVASIVE COROENT SYSTEM	Feb 07, 2005	Substantially Equivalent	Nuvasive, Inc.
K043316	RABEA SPINAL IMPLANT	Feb 07, 2005	Substantially Equivalent	Signus Medizintechnik GmbH
K041798	ATALIA TITANIUM SURGICAL MESH	Feb 07, 2005	Substantially Equivalent	Us Spinal Technologies, LLC
K043206	PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)	Jan 21, 2005	Substantially Equivalent	Pioneer Surgical Technology
K043566	MODIFICATION TO VERTE-STACK SPINAL SYSTEM	Jan 07, 2005	Substantially Equivalent	Medtronic Sofamor Danek
K043561	MODIFICATION TO VERTE-STACK SPINAL SYSTEM	Dec 29, 2004	Substantially Equivalent	Medtronic Sofamor Danek
K042714	FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4	Dec 29, 2004	Substantially Equivalent	Spine Next America Corporation
K042713	FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5	Dec 29, 2004	Substantially Equivalent	Spine Next America Corporation
K041407	TITANIUM MESH IMPLANT	Dec 29, 2004	Substantially Equivalent	Interpore Cross Intl.
K042930	SPACEVISION CAGE SYSTEM	Dec 28, 2004	Substantially Equivalent	Spine Vision, Inc.
K042268	EBI CAS SPINE SPACER SYSTEM	Oct 27, 2004	Substantially Equivalent	Ebi, L.P.
K042201	NOVEL VBR SPINAL SYSTEM	Oct 07, 2004	Substantially Equivalent	Alphatec/Nexmed
K041389	SYNTHES CONTOURED SYNMESH SPACER	Oct 01, 2004	Substantially Equivalent	Synthes Spine
K041722	MODIFICATION TO VBR SPINAL SYSTEM	Sep 23, 2004	Substantially Equivalent	Depuy Spine, Inc.
K041617	STALIF TT	Sep 08, 2004	Substantially Equivalent	Surgicraft , Ltd.
K040928	EXPANDABLE PEEK VBR IMPLANT	Aug 27, 2004	Substantially Equivalent	Interpore Cross Intl.
K041939	BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS	Aug 17, 2004	Substantially Equivalent	Blackstone Medical, Inc.
K041888	CURVED PEEK TETRIS SPINAL IMPLANT	Aug 10, 2004	Substantially Equivalent	Signus Medizintechnik GmbH
K041197	MODIFICATION TO VERTE-STACK SPINAL SYSTEM	Aug 09, 2004	Substantially Equivalent	Medtronic Sofamor Danek
K040731	STRYKER SPINE VERTEBRAL SPACER	Aug 05, 2004	Substantially Equivalent	Stryker Spine
K033926	HOURGLASS VERTEBRAL BODY SPACER	Jul 07, 2004	Substantially Equivalent	Medtronic Sofamor Danek
K041556	MODIFICATION TO VERTE-STACK SPINAL SYSTEM	Jul 01, 2004	Substantially Equivalent	Medtronic Sofamor Danek
K041452	MODIFICATION TO VERTE-STACK SPINAL SYSTEM	Jun 24, 2004	Substantially Equivalent	Medtronic Sofamor Danek
K033663	SPINAL CONCEPTS INC. CODA	May 27, 2004	Substantially Equivalent	Spinal Concepts, Inc.
K040536	MODIFICATION TO VERTE-STACK SPINAL SYSTEM	May 05, 2004	Substantially Equivalent	Medtronic Sofamor Danek
K040482	EBI ESL SPINE SPACER SYSTEM	Apr 16, 2004	Substantially Equivalent	Ebi, L.P.
K040168	MODIFICATION TO GEO STRUCTURE	Apr 08, 2004	Substantially Equivalent	Interpore Cross Intl.
K033702	BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM	Mar 31, 2004	Substantially Equivalent	Blackstone Medical, Inc.
K040284	SUSTAIN RADIOLUCENT SPACER	Mar 23, 2004	Substantially Equivalent	Globus Medical, Inc.
K033109	ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS	Mar 23, 2004	Substantially Equivalent	Scient'X
K040422	MODIFICATION TO VERTE-STACK	Mar 19, 2004	Substantially Equivalent	Medtronic Sofamor Danek
K032064	THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM	Feb 20, 2004	Substantially Equivalent	Theken Surgical,Llc
K040167	VERTE-STACK SPINAL SYSTEM	Feb 18, 2004	Substantially Equivalent for Some Indications	Medtronic Sofamor Danek
K033517	SPINAL CONCEPTS INC. CADENCE AND TRAXIS	Feb 18, 2004	Substantially Equivalent	Spinal Concepts, Inc.
K032371	TITANIUM MESH SYSTEM	Feb 12, 2004	Substantially Equivalent	Encore Medical L.P.
K033837	STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM	Jan 08, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K032812	ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT	Dec 08, 2003	Substantially Equivalent	Orthovita, Inc.
K032476	NUVASIVE MESH	Nov 13, 2003	Substantially Equivalent	Nuvasive, Inc.
K032527	HEDROCEL VERTEBRAL BODY REPLACEMENT	Oct 31, 2003	Substantially Equivalent	Implex Corp.
K032700	BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS	Oct 09, 2003	Substantially Equivalent	Blackstone Medical, Inc.
K031672	SPINAL CONCEPTS, INC. INFIX SYSTEM	Aug 07, 2003	Substantially Equivalent	Spinal Concepts, Inc.
K031780	VERTE-STACK SPINAL SYSTEM	Jul 30, 2003	Substantially Equivalent	Medtronic Sofamor Danek
K031757	PEEK TETRIS SPINAL IMPLANT	Jul 30, 2003	Substantially Equivalent	Signus Medical, LLC
K031914	SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE	Jul 12, 2003	Substantially Equivalent	Spinal Concepts, Inc.
K031823	HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1	Jul 11, 2003	Substantially Equivalent	Implex Corp.
K031302	SUSTAIN SPACER	Jun 27, 2003	Substantially Equivalent	Globus Medical, Inc.
K030744	BLACKSTONE SURGICAL TITANIUM MESH	Jun 27, 2003	Substantially Equivalent	Blackstone Medical, Inc.
K031635	DEPUY ACROMED VBR SYSTEM	Jun 23, 2003	Substantially Equivalent	Depuyacromed
K030735	MODIFIED VERTE-STACK SPINAL SYSTEM	Apr 18, 2003	Substantially Equivalent	Medtronic Sofamor Danek
K030833	DEPUY ACROMED VBR SYSTEM	Apr 10, 2003	Substantially Equivalent	Depuyacromed
K022793	TETRIS SPINAL IMPLANT	Apr 08, 2003	Substantially Equivalent	Signus Medical, LLC
K030736	VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES	Apr 02, 2003	Substantially Equivalent	Medtronic Sofamor Danek
K030601	VERTE-STACK SPINAL SYSTEM	Mar 25, 2003	Substantially Equivalent	Medtronic Sofamor Danek
K024364	SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)	Mar 17, 2003	Substantially Equivalent	Synthes (Usa)
K023319	NUVASIVE MASH	Mar 04, 2003	Substantially Equivalent	Nuvasive, Inc.
K024049	VERTE-SPAN SPINAL SYSTEM	Feb 26, 2003	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K030249	SURGICAL TITANIUM MESH SYSTEM	Feb 14, 2003	Substantially Equivalent	Depuyacromed
K023835	DEVEX MESH SYSTEM	Jan 29, 2003	Substantially Equivalent	Depuyacromed
K022143	INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)	Jan 23, 2003	Substantially Equivalent	Interpore Cross Intl.
K023570	MODIFICATION TO VERTE-STACK SPINAL SYSTEM	Nov 19, 2002	Substantially Equivalent	Medtronic Sofamor Danek
K022563	HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1	Aug 30, 2002	Substantially Equivalent	Implex Corp.
K021791	VERTE-STACK SPINAL SYSTEM	Aug 26, 2002	Substantially Equivalent	Medtronic Sofamor Danek
K021967	HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2	Jul 17, 2002	Substantially Equivalent	Implex Corp.
K011037	VERTEBRAL SPACER	Jul 01, 2002	Substantially Equivalent	Synthes (Usa)
K021025	MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ	May 20, 2002	Substantially Equivalent	Implex Corp.
K020887	EBI AIS SPINE SYSTEM	May 16, 2002	Substantially Equivalent	Ebi, L.P.
K020152	SYNTHES VERTEBRAL SPACER TI	Apr 16, 2002	Substantially Equivalent	Synthes (Usa)
K020522	MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM	Mar 21, 2002	Substantially Equivalent	Depuyacromed
K020204	TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189	Feb 21, 2002	Substantially Equivalent	Interpore Cross Intl.
K020048	MODIFICATION TO GEO STRUCTURE	Feb 06, 2002	Substantially Equivalent	Interpore Cross Intl.
K010378	HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ	Jan 28, 2002	Substantially Equivalent	Implex Corp.
K014145	MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131	Jan 17, 2002	Substantially Equivalent	Interpore Cross Intl.
K011406	SPINAL MESH SYSTEM	Dec 27, 2001	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K013382	MODIFICATION TO: STACKABLE CAGE SYSTEM	Nov 07, 2001	Substantially Equivalent	Depuyacromed
K010989	TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131	Nov 07, 2001	Substantially Equivalent	Interpore Cross Intl.
K010930	LIFT VB SPINAL SYSTEM	Oct 24, 2001	Substantially Equivalent	Medtronic Sofamor Danek, Inc.
K012254	VBR	Oct 16, 2001	Substantially Equivalent	Osteotech, Inc.
K010530	GEO STRUCTURE	Aug 03, 2001	Substantially Equivalent	Interpore Cross Intl.
K003709	SURGICAL DYNAMICS MESH CAGE SYSTEM	Jul 18, 2001	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K003836	SYNTHES SYNEX SPACER SYSTEM	May 29, 2001	Substantially Equivalent	Synthes
K003043	SURGICAL TITANIUM MESH SYSTEM	May 08, 2001	Substantially Equivalent	Depuyacromed
K003275	SYNTHES SYNMESH SPACER SYSTEM	Apr 23, 2001	Substantially Equivalent	Synthes (Usa)
K003155	VERTEBRAL BODY REPLACEMENT	Jan 04, 2001	Substantially Equivalent	Osteotech, Inc.
K001340	STACKABLE CAGE SYSTEM	Jul 26, 2000	Substantially Equivalent	Depuyacromed
K983667	IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE	Jul 05, 2000	Substantially Equivalent	Ionics Medical Corp.
K990148	STACKABLE CAGE SYSTEM	Sep 03, 1999	Substantially Equivalent	Depuy Motech Acromed