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 2004-07-07

HOURGLASS VERTEBRAL BODY SPACER

Applicant Medtronic Sofamor Danek

K number K033926

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MQP 2004-07-01

MODIFICATION TO VERTE-STACK SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K041556

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MQP 2004-06-24

MODIFICATION TO VERTE-STACK SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K041452

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MQP 2004-05-27

SPINAL CONCEPTS INC. CODA

Applicant Spinal Concepts, Inc.

K number K033663

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MQP 2004-05-05

MODIFICATION TO VERTE-STACK SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K040536

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MQP 2004-04-16

EBI ESL SPINE SPACER SYSTEM

Applicant Ebi, L.P.

K number K040482

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MQP 2004-04-08

MODIFICATION TO GEO STRUCTURE

Applicant Interpore Cross Intl.

K number K040168

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MQP 2004-03-31

BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM

Applicant Blackstone Medical, Inc.

K number K033702

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MQP 2004-03-23

SUSTAIN RADIOLUCENT SPACER

Applicant Globus Medical, Inc.

K number K040284

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MQP 2004-03-23

ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS

Applicant Scient'X

K number K033109

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MQP 2004-03-19

MODIFICATION TO VERTE-STACK

Applicant Medtronic Sofamor Danek

K number K040422

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MQP 2004-02-20

THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM

Applicant Theken Surgical,Llc

K number K032064

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MQP 2004-02-18

VERTE-STACK SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K040167

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MQP 2004-02-18

SPINAL CONCEPTS INC. CADENCE AND TRAXIS

Applicant Spinal Concepts, Inc.

K number K033517

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MQP 2004-02-12

TITANIUM MESH SYSTEM

Applicant Encore Medical L.P.

K number K032371

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MQP 2004-01-08

STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM

Applicant Howmedica Osteonics Corp.

K number K033837

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MQP 2003-12-08

ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT

Applicant Orthovita, Inc.

K number K032812

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MQP 2003-11-13

NUVASIVE MESH

Applicant Nuvasive, Inc.

K number K032476

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MQP 2003-10-31

HEDROCEL VERTEBRAL BODY REPLACEMENT

Applicant Implex Corp.

K number K032527

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MQP 2003-10-09

BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS

Applicant Blackstone Medical, Inc.

K number K032700

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MQP 2003-08-07

SPINAL CONCEPTS, INC. INFIX SYSTEM

Applicant Spinal Concepts, Inc.

K number K031672

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MQP 2003-07-30

VERTE-STACK SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K031780

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MQP 2003-07-30

PEEK TETRIS SPINAL IMPLANT

Applicant Signus Medical, LLC

K number K031757

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MQP 2003-07-12

SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE

Applicant Spinal Concepts, Inc.

K number K031914

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MQP 2003-07-11

HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1

Applicant Implex Corp.

K number K031823

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MQP 2003-06-27

SUSTAIN SPACER

Applicant Globus Medical, Inc.

K number K031302

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MQP 2003-06-27

BLACKSTONE SURGICAL TITANIUM MESH

Applicant Blackstone Medical, Inc.

K number K030744

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MQP 2003-06-23

DEPUY ACROMED VBR SYSTEM

Applicant Depuyacromed

K number K031635

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MQP 2003-04-18

MODIFIED VERTE-STACK SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K030735

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MQP 2003-04-10

DEPUY ACROMED VBR SYSTEM

Applicant Depuyacromed

K number K030833

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MQP 2003-04-08

TETRIS SPINAL IMPLANT

Applicant Signus Medical, LLC

K number K022793

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MQP 2003-04-02

VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES

Applicant Medtronic Sofamor Danek

K number K030736

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MQP 2003-03-25

VERTE-STACK SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K030601

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MQP 2003-03-17

SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)

Applicant Synthes (Usa)

K number K024364

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MQP 2003-03-04

NUVASIVE MASH

Applicant Nuvasive, Inc.

K number K023319

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MQP 2003-02-26

VERTE-SPAN SPINAL SYSTEM

Applicant Medtronic Sofamor Danek, Inc.

K number K024049

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MQP 2003-02-14

SURGICAL TITANIUM MESH SYSTEM

Applicant Depuyacromed

K number K030249

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MQP 2003-01-29

DEVEX MESH SYSTEM

Applicant Depuyacromed

K number K023835

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MQP 2003-01-23

INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)

Applicant Interpore Cross Intl.

K number K022143

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MQP 2002-11-19

MODIFICATION TO VERTE-STACK SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K023570

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MQP 2002-08-30

HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1

Applicant Implex Corp.

K number K022563

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MQP 2002-08-26

VERTE-STACK SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K021791

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MQP 2002-07-17

HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2

Applicant Implex Corp.

K number K021967

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MQP 2002-07-01

VERTEBRAL SPACER

Applicant Synthes (Usa)

K number K011037

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MQP 2002-05-20

MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ

Applicant Implex Corp.

K number K021025

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MQP 2002-05-16

EBI AIS SPINE SYSTEM

Applicant Ebi, L.P.

K number K020887

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MQP 2002-04-16

SYNTHES VERTEBRAL SPACER TI

Applicant Synthes (Usa)

K number K020152

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MQP 2002-03-21

MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM

Applicant Depuyacromed

K number K020522

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MQP 2002-02-21

TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189

Applicant Interpore Cross Intl.

K number K020204

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MQP 2002-02-06

MODIFICATION TO GEO STRUCTURE

Applicant Interpore Cross Intl.

K number K020048

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MQP 2002-01-28

HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ

Applicant Implex Corp.

K number K010378

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MQP 2002-01-17

MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131

Applicant Interpore Cross Intl.

K number K014145

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MQP 2001-12-27

SPINAL MESH SYSTEM

Applicant Medtronic Sofamor Danek, Inc.

K number K011406

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MQP 2001-11-07

MODIFICATION TO: STACKABLE CAGE SYSTEM

Applicant Depuyacromed

K number K013382

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MQP 2001-11-07

TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131

Applicant Interpore Cross Intl.

K number K010989

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MQP 2001-10-24

LIFT VB SPINAL SYSTEM

Applicant Medtronic Sofamor Danek, Inc.

K number K010930

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MQP 2001-10-16

VBR

Applicant Osteotech, Inc.

K number K012254

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MQP 2001-08-03

GEO STRUCTURE

Applicant Interpore Cross Intl.

K number K010530

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MQP 2001-07-18

SURGICAL DYNAMICS MESH CAGE SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K003709

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MQP 2001-05-29

SYNTHES SYNEX SPACER SYSTEM

Applicant Synthes

K number K003836

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MQP 2001-05-08

SURGICAL TITANIUM MESH SYSTEM

Applicant Depuyacromed

K number K003043

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MQP 2001-04-23

SYNTHES SYNMESH SPACER SYSTEM

Applicant Synthes (Usa)

K number K003275

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MQP 2001-01-04

VERTEBRAL BODY REPLACEMENT

Applicant Osteotech, Inc.

K number K003155

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MQP 2000-07-26

STACKABLE CAGE SYSTEM

Applicant Depuyacromed

K number K001340

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MQP 2000-07-05

IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE

Applicant Ionics Medical Corp.

K number K983667

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MQP 1999-09-03

STACKABLE CAGE SYSTEM

Applicant Depuy Motech Acromed

K number K990148

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