FDA Product Code
FDA Product Code MAX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3080
510(k) Clearances — 896 records · page 1 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261049 | SCALA® TL | Spineart SA | 2026-08-20 | Traditional | PDF ↗ |
| K261430 | TruLift Expandable System | Life Spine, Inc. | 2026-07-28 | Traditional | PDF ↗ |
| K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 | Traditional | PDF ↗ |
| K261020 | Symmetrix L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026-07-14 | Traditional | PDF ↗ |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | SeaSpine Orthopedics Corporation | 2026-07-01 | Traditional | PDF ↗ |
| K253151 | Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-15 | Traditional | PDF ↗ |
| K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | 2026-05-29 | Traditional | PDF ↗ |
| K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | 2026-05-28 | Traditional | PDF ↗ |
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | 2026-05-15 | Traditional | PDF ↗ |
| K260837 | VersaLift Expandable System | Life Spine, Inc. | 2026-05-12 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K261067 | BEE PLIF Cage | NGMedical GmbH | 2026-04-30 | Special | PDF ↗ |
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | 2026-02-26 | Traditional | PDF ↗ |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | 2026-02-23 | Traditional | PDF ↗ |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026-02-04 | Traditional | PDF ↗ |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | 2026-01-23 | Traditional | PDF ↗ |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | 2026-01-08 | Special | PDF ↗ |
| K253577 | IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | 2025-12-19 | Special | PDF ↗ |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025-11-25 | Special | PDF ↗ |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | 2025-10-28 | Traditional | PDF ↗ |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025-10-24 | Special | PDF ↗ |
| 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 (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) | Mobarn Medical Devices, LLC | 2025-09-18 | Traditional | PDF ↗ |
| K251444 | Endoskeleton Interbody Systems | Medtronic Sofamor Danek USA, Inc. | 2025-09-04 | Traditional | PDF ↗ |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | Atlas Spine, Inc. | 2025-08-15 | Traditional | PDF ↗ |
| K252113 | PRADO Lumbar Interbody Fusion System | Bethesda Medical Devices | 2025-08-05 | Special | PDF ↗ |
| K251016 | MectaLIF 3D Metal | Medacta International S.A. | 2025-07-17 | Traditional | PDF ↗ |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2025-07-08 | Special | PDF ↗ |
| 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 Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams | Carlsmed, Inc. | 2025-07-07 | Traditional | PDF ↗ |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine, Inc. | 2025-07-07 | Traditional | PDF ↗ |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. | 2025-06-30 | Traditional | PDF ↗ |
| K243816 | Testa TP Pivoting Spacer System | Spine Wave, Inc. | 2025-06-27 | Traditional | PDF ↗ |
| K251003 | X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025-06-25 | Traditional | PDF ↗ |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025-06-16 | Special | PDF ↗ |
| K243973 | FIX-L PEEK PLIF and T-PLIF System | Jeil Medical Corporation | 2025-06-12 | Traditional | PDF ↗ |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | Acuity Surgical Devices, LLC | 2025-06-02 | Traditional | PDF ↗ |
| K243116 | FlareHawk Interbody Fusion System | Integrity Implants Inc. Dba Accelus | 2025-05-21 | Traditional | PDF ↗ |
| K250669 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2025-04-22 | Traditional | PDF ↗ |
| K250373 | ProLift Expandable Spacer System | Life Spine, Inc. | 2025-04-09 | Traditional | PDF ↗ |
| K250667 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025-04-04 | Special | PDF ↗ |
| K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025-04-04 | Traditional | PDF ↗ |
| K250186 | GoLIF! Lumbar Interbody Fusion System | Getset Surgical, SA | 2025-03-21 | Traditional | PDF ↗ |
| K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | 2025-03-20 | Traditional | PDF ↗ |
| K241783 | FortiVy OsteoVy Lumbar IBF | Vy Spine, LLC | 2025-03-18 | Traditional | PDF ↗ |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | Alphatec Spine | 2025-02-03 | Traditional | PDF ↗ |
| K243739 | AxCess® Expandable Interbody System | Elliquence, LLC | 2025-01-24 | Traditional | PDF ↗ |
| K243668 | ProLift Pivot Expandable Spacer System | Life Spine, Inc. | 2025-01-23 | Traditional | PDF ↗ |
| K243670 | Idys® LIF | Clariance | 2024-12-31 | Special | PDF ↗ |
| K241073 | DZ-Tabone Intervertebral Body Fusion Device | Shenzhen Dazhou Medical Technology Co., Ltd. | 2024-12-06 | Traditional | PDF ↗ |
| K242589 | Scarlet® AL-T | Spineart SA | 2024-10-23 | Traditional | PDF ↗ |
| K242829 | BluEX Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. | 2024-10-23 | Traditional | PDF ↗ |
| K233947 | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System | Ctl Medical Corporation | 2024-10-10 | Traditional | PDF ↗ |
| K242826 | ProLift Wedge Expandable Spacer System | Life Spine, Inc. | 2024-10-08 | Traditional | PDF ↗ |
| K242267 | Gemini Medical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2024-10-08 | Traditional | PDF ↗ |
| K242457 | EARP Interbody System | Retropsoas Technologies, LLC | 2024-10-07 | Special | PDF ↗ |
| K242364 | IdentiTi II Interbody System | Alphatec Spine, Inc. | 2024-10-04 | Traditional | PDF ↗ |
| K240889 | ARTFX Lumbar PEEK Cages | Artfx Medical | 2024-10-02 | Traditional | PDF ↗ |
| K233807 | LumiVy Lumbar IBF System | Vy Spine, LLC | 2024-09-24 | Traditional | PDF ↗ |
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Alphatec Spine, Inc. | 2024-09-20 | Traditional | PDF ↗ |
| K241332 | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | 2024-09-20 | Traditional | PDF ↗ |
| K242509 | HAnano InterFuse(R) Modular Interbody | Next Orthosurgical | 2024-09-19 | Special | PDF ↗ |
| K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. | 2024-09-17 | Traditional | PDF ↗ |
| K241438 | Signus Tetris St; Signus Tetris R St | Signus Medizintechnik GmbH | 2024-09-11 | Traditional | PDF ↗ |
| K241164 | IB3D PL Spinal System | Medicrea International S.A.S. (Medtronic) | 2024-09-06 | Traditional | PDF ↗ |
| K234035 | COSINE Spacer | Globus Medical, Inc. | 2024-09-06 | Traditional | PDF ↗ |
| K232996 | Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) | Shanghai Iatrical-Ti Technologies CO , Ltd. | 2024-09-06 | Traditional | PDF ↗ |
| K241605 | Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology | Nanovis, LLC | 2024-09-05 | Traditional | PDF ↗ |
| K241328 | aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) | Carlsmed, Inc. | 2024-08-12 | Traditional | PDF ↗ |
| K240326 | Solar Lumbar Interbody Fusion System | Degen Medical, Inc. | 2024-07-29 | Traditional | PDF ↗ |
| K241413 | sagAlign Lumbar Cage System (Various PNs) | Acuity Surgical Devices, LLC | 2024-07-17 | Traditional | PDF ↗ |
| K234077 | SPIRA® Anterior Lumbar Spacers | Camber Spine Technologies | 2024-07-12 | Traditional | PDF ↗ |
| K241019 | aprevo® TLIF-C Articulating System | Carlsmed | 2024-07-09 | Traditional | PDF ↗ |
| K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System | Orthofix Medical, Inc. | 2024-06-20 | Traditional | PDF ↗ |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2024-06-20 | Special | PDF ↗ |
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | Orthofix, Inc. | 2024-05-28 | Traditional | PDF ↗ |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | SeaSpine Orthopedics Corporation | 2024-04-26 | Traditional | PDF ↗ |
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | Zavation Medical Products, LLC | 2024-04-10 | Traditional | PDF ↗ |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) | Icotec AG | 2024-04-05 | Traditional | PDF ↗ |
| K234150 | Lucent® XP | Spinal Elements | 2024-03-27 | Traditional | PDF ↗ |
| K232282 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | 2024-03-22 | Traditional | PDF ↗ |
| K233375 | Tranquil-L Interbody System | Nexus Spine, LLC | 2024-03-20 | Special | PDF ↗ |
| K233075 | BioGend Interbody Fusion System 001 Cage | Biogend Therapeutics Co., Ltd. | 2024-03-06 | Traditional | PDF ↗ |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion System | Restor3D | 2024-01-22 | Special | PDF ↗ |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System | Curiteva, Inc. | 2024-01-18 | Traditional | PDF ↗ |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2024-01-12 | Traditional | PDF ↗ |
| K230872 | Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System | Shanghai Sanyou Medical Co, Ltd. | 2023-12-12 | Traditional | PDF ↗ |
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System | Corelink, LLC | 2023-12-08 | Traditional | PDF ↗ |
| K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System | Life Spine, Inc. | 2023-11-30 | Traditional | PDF ↗ |
| K232069 | Expandable Lumbar Fusion Cage (Type I,Type II) | Shanghai Reach Medical Instrument Co, Ltd. | 2023-11-29 | Traditional | PDF ↗ |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 2023-11-07 | Traditional | PDF ↗ |
| K232504 | Calibrate CCX Interbody System | Alphatec Spine, Inc. | 2023-10-13 | Traditional | PDF ↗ |
| K232014 | CONDUIT ATP Inserters | Enztec Limited | 2023-09-01 | Special | PDF ↗ |
| K231680 | AccelFix Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. | 2023-08-24 | Special | PDF ↗ |
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Globus Medical, Inc. | 2023-08-03 | Traditional | PDF ↗ |
| K231275 | Exceed Biplanar Expandable Interbody System | Spine Wave, Inc. | 2023-07-25 | Traditional | PDF ↗ |
| K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | 2023-07-13 | Traditional | PDF ↗ |
| K231241 | NanoHive Medical Lumbar Interbody System | NanoHive Medical, LLC | 2023-07-12 | Traditional | PDF ↗ |
| K230942 | SPIRA® Posterior Lumbar Spacers | Camber Spine Technologies | 2023-07-11 | Traditional | PDF ↗ |
| K231252 | Ventana L Spinal System | Spinal Elements, Inc. | 2023-06-30 | Traditional | PDF ↗ |
| K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023-06-16 | Traditional | PDF ↗ |
| K231359 | RODIN Expandable Lumbar Cage System | Ctl Medical Corporation | 2023-06-09 | Special | PDF ↗ |
Product code MAX · Class II · Orthopedic. Data: openFDA.