Intervertebral Fusion Device With Bone Graft, Lumbar

FDA product code MAX · 785 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3080
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2007-10-11 – 2026-08-20

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

MAX 2010-06-02

CLYDESDALE SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K100175

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MAX 2010-05-19

IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF

Applicant Medicrea Technologies

K number K083798

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MAX 2010-05-13

SYNTHES T-PAL SPACER

Applicant Synthes Spine

K number K100089

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MAX 2010-04-28

EPICAGE INTERBODY FUSION DEVICE

Applicant R Tree Innovations

K number K092901

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MAX 2010-04-26

CRESCENT SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K094025

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MAX 2010-03-18

SEC IBF CAGE

Applicant Innvotec Surgical, Inc.

K number K093669

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MAX 2010-03-11

AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX

Applicant Stryker Corp.

K number K093864

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MAX 2010-02-25

BINDER INTERVERTEBRAL BODY FUSION DEVICE

Applicant Binder Biomedical, Inc.

K number K093015

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MAX 2010-02-04

ESL SPINAL SYSTEM

Applicant Ebi, L.P.

K number K092574

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MAX 2010-02-02

ATLAS INTERVERTEBRAL BODY CAGE

Applicant Spinal Edge, LLC

K number K092774

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MAX 2010-01-28

VALEO SPACER SYSTEM

Applicant Amedica Corp.

K number K091278

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MAX 2010-01-06

4CIS PEEK, PLIF AND TLIF CAGE SYSTEM

Applicant Solco Biomedical Co., Ltd.

K number K092162

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MAX 2009-12-23

AVS PL PEEK SPACERS

Applicant Stryker Corp.

K number K093704

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MAX 2009-12-23

INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076

Applicant Vertebral Technologies, Inc.

K number K093675

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MAX 2009-12-23

PATRIOT TRANSCONTINENTAL LLIF SPACER

Applicant Globus Medical, Inc.

K number K093242

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MAX 2009-12-01

PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)

Applicant Captiva Spine, Inc.

K number K092017

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MAX 2009-10-19

DISTRACTABLE WAVE CAGE

Applicant Advanced Medical Technology, Inc.

K number K083626

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MAX 2009-09-29

PERIMETER INTERBODY FUSION DEVICE

Applicant Medtronic Sofamor Danek

K number K090353

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MAX 2009-09-25

SPINAL USA INTERBODY CAGES

Applicant Spinal USA

K number K092193

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MAX 2009-09-18

DIANA FUSION CAGE

Applicant Signus Medical

K number K091122

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MAX 2009-09-14

DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031

Applicant Spinefrontier, Inc.

K number K091638

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MAX 2009-08-14

ASFORA BULLET CAGE SYSTEM

Applicant Medical Designs, LLC

K number K090048

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MAX 2009-08-07

IBEX SPINAL SYSTEM

Applicant Ebi, L.P.

K number K091381

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MAX 2009-07-30

MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076

Applicant Vertebral Technologies, Inc.

K number K091988

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MAX 2009-07-15

TALOS INTERVERTEBRAL BODY FUSION DEVICE

Applicant Meditech Advisors, LLC

K number K090707

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MAX 2009-06-25

MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM

Applicant Ldr Spine USA

K number K090507

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MAX 2009-06-01

PATHWAY AVID

Applicant Custom Spine, Inc.

K number K090566

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MAX 2009-05-22

DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS

Applicant Depuy Spine, Inc.

K number K081917

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MAX 2009-05-19

DEPUY SPINE LATERAL SYSTEM

Applicant Depuy Spine, Inc.

K number K090899

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MAX 2009-05-19

GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM

Applicant Alphatec Spine, Inc.

K number K090425

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MAX 2009-04-24

STRYKER SPINE AVS PL PEEK SPACERS

Applicant Stryker Corp.

K number K090816

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MAX 2009-04-22

NOVEL ALIF SPINAL SPACER SYSTEM

Applicant Alphatec Spine, Inc.

K number K090782

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MAX 2009-04-22

AVS ANTERIOR LARGE PEEK SPACERS

Applicant Stryker Corp.

K number K090166

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MAX 2009-04-21

ALEUTIAN IBF SYSTEM

Applicant K2m, Inc.

K number K082698

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MAX 2009-04-20

LANX FUSION SYSTEM

Applicant Lanx, Inc.

K number K083815

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MAX 2009-04-15

ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)

Applicant Titan Spine, LLC

K number K083714

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MAX 2009-04-09

EMINENT SPINE INTERBODY FUSION SYSTEM

Applicant Eminent Spine

K number K090064

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MAX 2009-04-01

SPINESMITH CYNCH SPINAL SYSTEM

Applicant Spine Smith Partners L.P.

K number K090376

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MAX 2009-02-27

AVS TL PEEK SPACERS

Applicant Stryker Corp.

K number K083661

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MAX 2009-02-06

DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE

Applicant Spineart

K number K081888

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MAX 2009-02-02

LDR SPINE ROI INTERBODY FUSION SYSTEM

Applicant Ldr Spine USA

K number K082262

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MAX 2009-01-14

EXPANDABLE PEEK-OPTIMA IMPLANT

Applicant Ebi, L.P.

K number K082406

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MAX 2009-01-02

THEKEN SPINE VU EPOD AND VU LPOD SYSTEM

Applicant Theken Spine, LLC

K number K082712

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MAX 2008-12-29

CLYDESDALE SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K083026

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MAX 2008-11-14

DEPUY SPINE LATERAL CAGE SYSTEM

Applicant Depuy Spine

K number K082128

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MAX 2008-11-14

DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE

Applicant Ionics Medical Corp.

K number K081673

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MAX 2008-11-10

HOLLYWOOD, PACIFICA, REDONDO, VENTURA

Applicant Seaspine, Inc.

K number K082310

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MAX 2008-10-21

LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE

Applicant Lanx, LLC

K number K082774

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MAX 2008-10-17

INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES

Applicant Calvary Spine, LLC

K number K082260

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MAX 2008-10-16

MODIFICATION TO: CAPSTONE SPINAL SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K number K082732

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MAX 2008-10-16

SPINAL USA VBR SYSTEM

Applicant Spinal USA

K number K081196

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MAX 2008-09-16

OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM

Applicant Vertiflex, Inc.

K number K082270

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MAX 2008-09-12

MODIFICATION TO CAPSTONE SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K082342

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MAX 2008-09-04

BLACKSTONE PILLAR XL PEEK SPACERS

Applicant Blackstone Medical, Inc.

K number K082235

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MAX 2008-08-07

PEEK-OPTIMA ALIF SPACER

Applicant Biomet Spine

K number K081636

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MAX 2008-08-05

MODIFICATION TO LUCENT

Applicant Spinal Elements, Inc.

K number K081968

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MAX 2008-07-28

STRYKER SPINE AVS PL PEEK SPACERS

Applicant Stryker Corp.

K number K082014

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MAX 2008-07-23

BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM

Applicant Blackstone Medical, Inc.

K number K081177

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MAX 2008-06-30

L-VARLOCK

Applicant Kiscomedica S.A.

K number K080537

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MAX 2008-06-17

ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)

Applicant Titan Spine, LLC

K number K080615

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MAX 2008-06-10

INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE

Applicant Vertebral Technologies, Inc.

K number K080673

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MAX 2008-05-30

SCIENT'X TRIBECA VBR

Applicant Scient'X USA, Inc.

K number K080588

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MAX 2008-05-15

PLATEAU SPACER SYSTEM

Applicant Life Spine

K number K080411

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MAX 2008-05-13

SPINAL USA INTERBODY FUSION DEVICE

Applicant Spinal USA

K number K080314

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MAX 2008-05-13

PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM

Applicant Pioneer Surgical Technology

K number K073177

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MAX 2008-05-09

SHELL CAGE, WAVE CAGE, LOOP CAGE

Applicant Advanced Medical Technologies AG

K number K080401

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MAX 2008-05-01

PATHWAY

Applicant Custom Spine, Inc.

K number K080281

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MAX 2008-05-01

AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE

Applicant Aesculap Implant Systems, Inc.

K number K071983

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MAX 2008-04-24

FOUNDATION CAGE

Applicant Corelink, LLC

K number K073440

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MAX 2008-04-24

CAPSTONE SPINAL SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K number K073291

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MAX 2008-04-16

TURBO PRIME IBD SYSTEM

Applicant Spineselect, LLC

K number K080058

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MAX 2008-04-10

INTREPID SPINAL SYSTEM

Applicant Medtronic Sofamor Danek

K number K080083

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MAX 2008-03-27

AVS PL PEEK SPACERS, MODELS 48351 AND 48353

Applicant Stryker Corp.

K number K080758

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MAX 2008-03-06

AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX

Applicant Stryker Spine

K number K073470

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MAX 2008-02-13

ORIA NATURA SPACER

Applicant Choicespine, LP

K number K073669

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MAX 2008-01-30

ARDIS SPACER

Applicant Abbott Spine, Inc.

K number K073202

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MAX 2008-01-24

LANX INTERVERTEBRAL BODY FUSION DEVICE

Applicant Lanx, LLC

K number K073144

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MAX 2008-01-18

PATRIOT SPACERS

Applicant Globus Medical, Inc.

K number K072970

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MAX 2007-12-26

LUCENT MAGNUM

Applicant Spinal Elements, Inc.

K number K073348

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MAX 2007-12-26

ORACLE SPACER, OPAL SPACER

Applicant Synthes Spine

K number K072791

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MAX 2007-12-10

IMPIX SPACER

Applicant Medicrea Technologies

K number K072226

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MAX 2007-12-04

NUVASIVE COROENT SYSTEM

Applicant Nuvasive, Inc.

K number K071795

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MAX 2007-11-09

LUCENT

Applicant Spinal Elements, Inc.

K number K071724

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MAX 2007-11-01

SPINEFRONTIER DORADO VBR

Applicant Spinefrontier, Inc.

K number K072289

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MAX 2007-10-11

PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE

Applicant Innovative Spinal Technologies, Inc.

K number K072120

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