Product code MAX
- 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.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P000028S008 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2006-07-25 |
| P970015S031 | INTER FIX TM THREADED FUSION DEVICE | Sofamor Danek | 2005-07-27 |
| P970015S029 | LT-CAGE LUMBAR TAPERED FUSION DEVICE | Sofamor Danek | 2005-07-22 |
| P970015S030 | LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK) | Sofamor Danek | 2005-02-04 |
| P980048S003 | BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE | Sulzer Spine-Tech | 2004-10-06 |
| P000028S006 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2004-08-24 |
| P970015S028 | INTER FIX THREADED FUSION DEVICE | Sofamor Danek | 2004-07-19 |
| P950002S014 | BAK VISTA INTERBODY FUSION CAGE | Zimmer Spine, Inc. | 2004-07-01 |
| P000028S005 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2004-06-18 |
| P970015S027 | LT-CAGE LUMBAR TAPERED FUSION DEVICE | Sofamor Danek | 2004-04-16 |
| P970015S026 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek | 2004-04-16 |
| P950019S014 | RAY TFC AND RAY TFC UNITE | Stryker Spine | 2004-03-25 |
| P950002S013 | VISTA LORDOTIC INTERBODY FUSION CAGE | Zimmer Spine, Inc. | 2004-01-29 |
| P000028S004 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2003-11-13 |
| P950002S012 | BAK VISTA INTERBODY FUSION CAGE | Zimmer Spine, Inc. | 2003-10-31 |
| P950019S016 | RAY TFC UNITE | Stryker Spine | 2003-10-10 |
| P970015S025 | INTER FIX THREADED FUSION DEVICE | Sofamor Danek | 2003-09-17 |
| P970015S022 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek | 2003-09-10 |
| P950019S015 | RAY THREADED FUSION CAGE (TFC) | Stryker Spine | 2003-09-04 |
| P950019S013 | RAY TFC UNITE PRODUCT LINE | Stryker Spine | 2003-07-15 |
| P950002S011 | BAK VISTA INTERBODY FUSION DEVICE | Zimmer Spine, Inc. | 2003-07-08 |
| P000028S003 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2003-07-02 |
| P970015S021 | INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE | Sofamor Danek | 2003-06-24 |
| P000028S002 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2002-12-03 |
| P000028S001 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2002-08-13 |
| P970015S020 | LT-CAGE TAPERED FUSION DEVICE | Sofamor Danek | 2002-08-12 |
| P980048S002 | BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech | 2002-06-19 |
| P000028 | AFFINITY (TM) CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2002-06-13 |
| P950002S007 | BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE | Zimmer Spine, Inc. | 2002-05-01 |
| P950019S012 | RAY TFC DEVICE/RAY TFC UNITE DEVICE | Stryker Spine | 2002-04-02 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | 2026-05-15 |
| K260837 | VersaLift Expandable System | Life Spine, Inc. | 2026-05-12 |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system | Carlsmed, Inc. | 2026-05-09 |
| K261067 | BEE PLIF Cage | NGMedical GmbH | 2026-04-30 |
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | 2026-02-26 |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | 2026-02-23 |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026-02-04 |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | 2026-01-23 |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | 2026-01-08 |
| K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | 2025-12-19 |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025-11-25 |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | 2025-10-28 |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025-10-24 |
| K251479 | Mobarn 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 (D... | Mobarn Medical Devices, LLC | 2025-09-18 |
| K251444 | Endoskeleton™ Interbody Systems | Medtronic Sofamor Danek USA, Inc. | 2025-09-04 |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | Atlas Spine, Inc. | 2025-08-15 |
| K252113 | PRADO™ Lumbar Interbody Fusion System | Bethesda Medical Devices | 2025-08-05 |
| K251016 | MectaLIF 3D Metal | Medacta International S.A. | 2025-07-17 |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2025-07-08 |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine, Inc. | 2025-07-07 |
| K250827 | aprevo® 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 A... | Carlsmed, Inc. | 2025-07-07 |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. | 2025-06-30 |
| K243816 | Testa TP Pivoting Spacer System | Spine Wave, Inc. | 2025-06-27 |
| K251003 | X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025-06-25 |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025-06-16 |
| K243973 | FIX-L PEEK PLIF and T-PLIF System | Jeil Medical Corporation | 2025-06-12 |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | Acuity Surgical Devices, LLC | 2025-06-02 |
| K243116 | FlareHawk Interbody Fusion System | Integrity Implants Inc. Dba Accelus | 2025-05-21 |
| K250669 | Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2025-04-22 |
| K250373 | ProLift Expandable Spacer System | Life Spine, Inc. | 2025-04-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810166522366 | X-PAC | EXPANDING INNOVATIONS, INC. | 2026-05-27 |
| 00810166522373 | X-PAC | EXPANDING INNOVATIONS, INC. | 2026-05-27 |
| B70712535005S0 | Dual X Graft Tamp Short | AMPLIFY SURGICAL, INC. | 2026-05-27 |
| B707129410010130 | DUALXS T/PLIF 15 DEG x 9-12MM | AMPLIFY SURGICAL, INC. | 2026-05-27 |
| B707129410010200 | DUALXS T/PLIF 18 DEG x 10-13MM | AMPLIFY SURGICAL, INC. | 2026-05-27 |
| 00197157075859 | ZAVATION INSERTER | Zavation LLC | 2026-05-27 |
| 07613153046424 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046578 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046431 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046448 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046455 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046462 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046479 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046486 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046493 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046509 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046530 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046547 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046417 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046400 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046394 | AVS TL | Stryker Corporation | 2015-09-14 |
| 07613153046363 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046356 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046332 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046325 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046301 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046233 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046219 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046202 | AVS PL | Stryker Corporation | 2015-09-14 |
| 07613153046196 | AVS PL | Stryker Corporation | 2015-09-14 |