FDA.report

Product code MAX

Current FDA Classification

Device name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3080
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Related PMA Records

PMADeviceApplicantDecision date
P970015S031INTER FIX TM THREADED FUSION DEVICESOFAMOR DANEK2005-07-27
P970015S029LT-CAGE LUMBAR TAPERED FUSION DEVICESOFAMOR DANEK2005-07-22
P970015S030LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK)SOFAMOR DANEK2005-02-04
P970015S028INTER FIX THREADED FUSION DEVICESOFAMOR DANEK2004-07-19
P970015S026LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICESOFAMOR DANEK2004-04-16
P970015S027LT-CAGE LUMBAR TAPERED FUSION DEVICESOFAMOR DANEK2004-04-16
P950019S014RAY TFC AND RAY TFC UNITESTRYKER SPINE2004-03-25
P950019S016RAY TFC UNITESTRYKER SPINE2003-10-10
P970015S025INTER FIX THREADED FUSION DEVICESOFAMOR DANEK2003-09-17
P970015S022LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICESOFAMOR DANEK2003-09-10
P950019S015RAY THREADED FUSION CAGE (TFC)STRYKER SPINE2003-09-04
P950019S013RAY TFC UNITE PRODUCT LINESTRYKER SPINE2003-07-15
P970015S021INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICESOFAMOR DANEK2003-06-24
P970015S020LT-CAGE TAPERED FUSION DEVICESOFAMOR DANEK2002-08-12
P950019S012RAY TFC DEVICE/RAY TFC UNITE DEVICESTRYKER SPINE2002-04-02
P970015S019DUAL INTERFIX-RP(TM) THREADED FUSION DEVICESOFAMOR DANEK2001-07-19
P970015S017INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILESOFAMOR DANEK2000-12-13
P970015S010LORDOTEC(TM) TAPERED FUSION DEVICESOFAMOR DANEK2000-09-28
P950019S011RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATIONSTRYKER SPINE2000-03-30
P950019S009RAY TFC DEVICE AND RAY TFC UNITE DEVICESTRYKER SPINE2000-03-02
P950019S010RAY THREADED FUSION CAGE(TFC)STRYKER SPINE1999-12-01
P950019S008RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATIONSTRYKER SPINE1999-10-04
P970015INTER FIX THREADED FUSION DEVICESOFAMOR DANEK1999-05-14
P950019S007RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATIONSTRYKER SPINE1999-03-19
P950019S006RAY FUSION THREADED CAGE (TFC) DEVICESTRYKER SPINE1999-02-05
P960025BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWSDEPUY SPINE,INC1999-02-02
P950019S005RAY TFC DEVICE INSTRUMENTATIONSTRYKER SPINE1998-10-29
P950019S004RAY TFC DEVICE WITH INSTRUMENTATIONSTRYKER SPINE1998-08-27
P950019S003RAY TFC DEVICE WITH INSTRUMENTATION (20MM)STRYKER SPINE1998-06-17
P950019S002RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATIONSTRYKER SPINE1998-06-08

Related 510(k) Records

510(k)DeviceApplicantDecision date
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K253583LUX Expandable Lumbar Interbody SystemXenix Medical2026-02-23
K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.2026-02-04
K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.2026-01-23
K253266Titanium Interbody SystemSpine Innovation, LLC2026-01-08
K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)2025-12-19
K252610ZSFab Lumbar Interbody SystemZsfab, Inc.2025-11-25
K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.2025-10-28
K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.2025-10-24
K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))Mobarn Medical Devices, LLC2025-09-18
K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.2025-09-04
K251969Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemAtlas Spine, Inc.2025-08-15
K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices2025-08-05
K251016MectaLIF 3D MetalMedacta International S.A.2025-07-17
K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.2025-07-08
K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.2025-07-07
K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No CamsCarlsmed, Inc.2025-07-07
K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.2025-06-30
K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.2025-06-27
K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.2025-06-25
K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.2025-06-16
K243973FIX-L PEEK PLIF and T-PLIF SystemJeil Medical Corporation2025-06-12
K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC2025-06-02
K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus2025-05-21
K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.2025-04-22
K250373ProLift Expandable Spacer SystemLife Spine, Inc.2025-04-09

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