Spinal Vertebral Body Replacement Device

FDA product code MQP · 266 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3060
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1999-09-03 – 2026-07-31

MQP 2026-07-31

Vertiwedge® Intraosseous System

Applicant Foundation Surgical Group

K number K261810

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MQP 2026-07-10

POSEIDON ST

Applicant Signus Medinzintechnik GmbH

K number K261031

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MQP 2026-01-07

VyBrate™ VBR System

Applicant Vy Spine, LLC

K number K253158

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MQP 2024-11-07

Vertiwedge® Intraosseous System

Applicant Foundation Surgical Group, Inc.

K number K241468

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MQP 2024-04-04

KONG®-TL VBR System and KONG® C VBR System

Applicant Icotec AG

K number K232790

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MQP 2024-03-08

DOMINION Expandable Corpectomy System

Applicant Astura Medical

K number K233359

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MQP 2024-02-13

VerteLoc Spinal System

Applicant Signature Orthopaedics Pty, Ltd.

K number K231134

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MQP 2023-10-06

Ascend VBR System, Ascend NanoTec VBR System

Applicant Alphatec Spine, Inc.

K number K232173

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MQP 2022-10-06

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)

Applicant Arftx Medical, LLC

K number K211892

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MQP 2020-12-23

F3D Corpectomy System

Applicant Corelink, LLC

K number K202637

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MQP 2020-05-29

KONG-TL VBR System, KONG-C VBR System

Applicant Icotec AG

K number K200235

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MQP 2020-02-26

NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System

Applicant Nu Vasive, Incorporated

K number K193506

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MQP 2019-11-01

Small VBR™

Applicant Ulrich GmbH & Co. KG

K number K192117

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MQP 2019-10-24

MediExpand TL Expandable VBR System

Applicant Cmf Medicon Surgical, Inc.

K number K190349

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MQP 2019-10-11

CarboClear VBR System

Applicant CarboFix Orthopedics , Ltd.

K number K192214

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MQP 2019-05-23

SYNMESH System

Applicant Depuy Synthes Spine

K number K183054

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MQP 2019-05-08

COLOSSEUM Mesh

Applicant Globus Medical, Inc.

K number K190147

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MQP 2019-04-04

PYRAMESH™ Implant System

Applicant Medtronic Sofamor Danek USA, Inc.

K number K183197

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MQP 2019-02-22

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System

Applicant Choicespine

K number K183588

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MQP 2019-01-16

T2 STRATOSPHERE Expandable Corpectomy System

Applicant Medtronic Sofamor Danek USA, Inc.

K number K183510

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MQP 2018-11-28

SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System

Applicant K2m, LLC

K number K180665

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MQP 2018-11-16

Solidity Vertebral Body Replacement

Applicant Ulrich Medical USA

K number K181921

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MQP 2018-09-19

T2 STRATOSPHERE™ Expandable Corpectomy System

Applicant Medtronic Sofamor Danek USA, Inc.

K number K181328

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MQP 2018-09-19

FORTIFY Corpectomy Spacers

Applicant Globus Medical, Inc.

K number K173982

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MQP 2018-06-11

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

Applicant Medos International SARL

K number K173787

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MQP 2018-02-02

Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage

Applicant Camber Spine Technologies

K number K173800

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MQP 2017-12-21

Blustone Synergy Silica System

Applicant Blustone Synergy

K number K172330

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MQP 2017-12-20

T2 STRATOSPHERE™ Expandable Corpectomy System

Applicant Medtronic Sofamor Danek

K number K173125

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MQP 2017-11-09

FORTIFY Corpectomy Spacers

Applicant Globus Medical, Inc.

K number K162315

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MQP 2017-10-26

Omnia Medical VBR

Applicant Omnia Medical, LLC

K number K172323

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MQP 2017-09-15

Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System

Applicant Choicespine

K number K171686

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MQP 2017-08-31

CAPRI Corpectomy Cage System

Applicant K2m

K number K171704

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MQP 2017-05-16

VerteFIT Corpectomy Cage System

Applicant Ldr Spine USA, Inc.

K number K162133

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MQP 2017-04-13

CAPRI Corpectomy Cage System

Applicant K2m

K number K170055

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MQP 2017-03-30

NuVasive(r) Monolith Corpectomy System

Applicant Nu Vasive, Incorporated

K number K170271

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MQP 2013-12-24

PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE

Applicant Pioneer Surgical Technology, Inc.

K number K131724

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MQP 2013-12-06

STAXX(R) SYSTEM

Applicant Spine Wave, Inc.

K number K133207

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MQP 2013-09-23

T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE

Applicant Medtronic Sofamor Danek, Inc.

K number K131888

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MQP 2012-09-19

ENDURAMESH

Applicant Lucero Medical, LLC

K number K122622

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MQP 2012-08-29

STAXX XD SYSTEM

Applicant Spine Wave, Inc.

K number K121889

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MQP 2012-08-17

STGC

Applicant Cardinal Spine, LLC

K number K121176

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MQP 2012-07-03

FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)

Applicant Globus Medical, Inc.

K number K121107

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MQP 2012-04-05

CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM

Applicant Choicespine, LP

K number K120570

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MQP 2012-01-27

SANTORINI SPINAL SYSTEM

Applicant K2m, Inc.

K number K111294

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MQP 2012-01-26

GIZA(R) VERTEBRAL BODY REPLACEMENT

Applicant Eden Spine, LLC

K number K112429

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MQP 2011-12-13

STAXX(R) XD SYSTEM

Applicant Spine Wave, Inc.

K number K111418

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MQP 2011-10-20

SYNTHES XRL

Applicant Synthes Spine Co.Lp

K number K103320

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MQP 2011-10-12

SFC VERTEBRAL BODY REPLACEMENT

Applicant Konigsee Implantate GmbH

K number K110153

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MQP 2011-10-07

FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS

Applicant Globus Medical, Inc.

K number K112756

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MQP 2011-08-19

STAXX XDL SYSTEM

Applicant Spine Wave, Inc.

K number K102315

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MQP 2011-07-21

DSC/ALF SPINAL SYSTEM

Applicant Sintea Plastek, LLC

K number K101886

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MQP 2011-07-19

STAXXSD SYSTEM

Applicant Spine Wave, Inc.

K number K111469

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MQP 2011-06-15

BIOSPINE VBR SYSTEM

Applicant Aesculap Implant Systems, LLC

K number K110864

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MQP 2010-11-30

STAXX(R) XD SYSTEM

Applicant Spine Wave, Inc.

K number K102682

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MQP 2010-10-21

T2 XVBR 1.5 SPINAL SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K number K100976

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MQP 2010-09-10

STAXX XD SYSTEM

Applicant Spine Wave, Inc.

K number K101288

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MQP 2010-04-26

ENDURAMESH, MODEL 762.XXX

Applicant Lucero Medical, LLC

K number K093207

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MQP 2010-03-04

TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET

Applicant Zimmer Trabecular Metal Technology

K number K093127

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MQP 2010-03-04

AESCULAP HYDROLIFT VBR SYSTEM

Applicant Aesculap Implant System, Inc.

K number K083186

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MQP 2009-12-23

CERVICORE CORPECTOMY CAGE

Applicant Verticor, Ltd.

K number K091426

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MQP 2009-11-02

SEC VBR

Applicant Innvotec Surgical, Inc.

K number K091743

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MQP 2009-10-15

C-THRU SPINAL SYSTEM

Applicant Ebi, L.P.

K number K092336

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MQP 2009-10-05

ADDPLUS

Applicant Ulrich GmbH & Co. KG

K number K090841

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MQP 2009-09-25

VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX

Applicant Stryker Spine

K number K091946

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MQP 2009-09-21

T2 SPINAL SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K number K091883

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MQP 2009-09-04

ATLAS SPINE SPACER

Applicant Atlas Spine, LLC

K number K091406

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MQP 2009-09-03

STAXX XD SYSTEM

Applicant Spine Wave, Inc.

K number K090315

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MQP 2009-04-27

NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM

Applicant Nuvasive, Inc.

K number K090176

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MQP 2009-02-12

LDR SPINE ROI-C IMPLANT

Applicant Ldr Spine USA

K number K083857

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MQP 2009-01-09

XYCOR SPINAL IMPLANT

Applicant Vertebration,Inc

K number K082466

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MQP 2008-08-27

T2 XVBR SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K082112

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MQP 2008-07-02

RELIANCE VBS SYSTEM

Applicant Reliance Medical Systems, LLC

K number K081383

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MQP 2008-07-02

SPINESMITH CIMPLICITY SPINAL SYSTEM

Applicant Spine Smith Partners L.P.

K number K080971

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MQP 2008-06-30

CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION

Applicant Creaspine

K number K081564

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MQP 2008-06-24

OSTAPEK VBR SYSTEM

Applicant Co-Ligne AG

K number K072326

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MQP 2008-06-10

ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM

Applicant Signus Medizintechnik GmbH

K number K081332

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MQP 2008-05-29

CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM

Applicant Creaspine

K number K080860

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MQP 2008-05-29

LDR SPINE ROI-C IMPLANT

Applicant Ldr Spine USA

K number K080728

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MQP 2008-05-21

NOVEL SPINAL SPACER SYSTEM

Applicant Alphatec Spine, Inc.

K number K080699

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MQP 2008-05-07

LDR SPINE ROI-T IMPLANT

Applicant Ldr Spine USA

K number K080569

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MQP 2008-05-01

X-MESH EXPANDABLE CAGE SYSTEM

Applicant Depuy Spine, Inc.

K number K080568

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MQP 2008-04-07

LDR SPINE ROI-A IMPLANT

Applicant Ldr Spine USA

K number K080572

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MQP 2008-03-24

VERTEBRON VBR SYSTEM

Applicant Vertebron, Inc.

K number K073502

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MQP 2008-03-10

KIMBA MINI

Applicant Signus Medizintechnik GmbH

K number K080349

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MQP 2008-01-25

BENGAL STACKABLE CAGE SYSTEM

Applicant Depuy Spine, Inc.

K number K073649

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MQP 2008-01-24

ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01

Applicant K2m, Inc.

K number K080024

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MQP 2008-01-09

MODIFICATION TO VALEO VBR

Applicant Amedica Corp.

K number K073505

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MQP 2007-12-18

CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM

Applicant Creaspine Sas

K number K072537

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MQP 2007-12-05

VALEO VBR

Applicant Amedica Corp.

K number K073125

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MQP 2007-10-23

ZUMA

Applicant Seaspine, Inc.

K number K071726

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MQP 2007-10-15

PHENIX VERTEBRAL BODY REPLACEMENT

Applicant New Business Development, LLC

K number K072029

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MQP 2007-10-04

NIKO CORPECTOMY SPACER

Applicant Globus Medical, Inc.

K number K072465

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MQP 2007-09-27

RELIANCE VBS SYSTEM

Applicant Reliance Medical Systems, LLC

K number K063637

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MQP 2007-08-31

TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155

Applicant Zimmer Trabecular Metal Technology

K number K070754

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MQP 2007-08-30

LDR SPINE ROI-T SYSTEM

Applicant Ldr Spine USA

K number K072132

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MQP 2007-08-24

GSO GS1 SPACER

Applicant Gold Standard Orthopedics, LLC

K number K071274

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MQP 2007-08-14

T2 XVBR SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K071033

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MQP 2007-07-30

VU E*POD VERTEBRAL BODY REPLACEMENT

Applicant Theken Spine, LLC

K number K071031

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MQP 2007-06-29

ATLAS SPINE VERTEBRAL BODY REPLACEMENT

Applicant Atlas Spine, Inc.

K number K071497

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MQP 2007-06-28

X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT

Applicant Theken Spine, LLC

K number K070786

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