FDA Product Code
FDA Product Code ODP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3080
510(k) Clearances — 354 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion System | Wenzel Spine, Inc. | 2026-08-26 | Special | PDF ↗ |
| K262489 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026-08-18 | Special | PDF ↗ |
| K253041 | 3d Cage Cervical | Fims Co., Ltd. | 2026-07-23 | Traditional | PDF ↗ |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | Stryker Spine | 2026-07-17 | Special | PDF ↗ |
| K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | 2026-07-08 | Special | PDF ↗ |
| K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026-05-16 | Traditional | PDF ↗ |
| K260850 | OSTEOMNI SPINAL CAGES SYSTEM | Osteomni, Inc. | 2026-05-12 | Traditional | PDF ↗ |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | 2026-04-24 | Special | PDF ↗ |
| K253260 | ORIO-3D Cage System | SpineCraft | 2026-04-16 | Traditional | PDF ↗ |
| K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC | 2026-04-13 | Traditional | PDF ↗ |
| K242303 | MOD-C | Orthomod, LLC | 2026-04-01 | Traditional | PDF ↗ |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026-03-30 | Traditional | PDF ↗ |
| K252432 | Flex-Z Cervical Cage | Spinepoint, LLC | 2026-03-25 | Traditional | PDF ↗ |
| K254105 | Hive Standalone Cervical System and Hive C Interbody System | NanoHive Medical, LLC | 2026-02-13 | Traditional | PDF ↗ |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2026-01-16 | Traditional | PDF ↗ |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2026-01-15 | Special | PDF ↗ |
| K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | 2026-01-14 | Traditional | PDF ↗ |
| K252711 | Advantage-C Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | 2026-01-08 | Traditional | PDF ↗ |
| K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026-01-06 | Traditional | PDF ↗ |
| K252781 | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. | 2025-12-19 | Traditional | PDF ↗ |
| K250764 | SpineLinc Anterior Cervical Implant System | Lincotek Medical | 2025-12-05 | Traditional | PDF ↗ |
| K250769 | Dakota LP System | Precision Spine, Inc. | 2025-11-24 | Traditional | PDF ↗ |
| K250560 | BEE HA | NGMedical GmbH | 2025-11-21 | Traditional | PDF ↗ |
| K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | 2025-11-21 | Traditional | PDF ↗ |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | 2025-10-10 | Traditional | PDF ↗ |
| K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | 2025-08-29 | Traditional | PDF ↗ |
| K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | 2025-07-03 | Traditional | PDF ↗ |
| K250605 | EVOL® ha Hyper C Cervical Interbody Fusion System | Cutting Edge Spine, LLC | 2025-03-12 | Special | PDF ↗ |
| K243915 | FIX-C 3D Ti ACIF System | Jeil Medical Corporation | 2025-02-18 | Traditional | PDF ↗ |
| K243673 | Xenco Medical CancelleX Cervical Interbody System | Xenco Medical, LLC | 2025-01-29 | Traditional | PDF ↗ |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024-11-15 | Traditional | PDF ↗ |
| K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | Zsfab | 2024-11-07 | Traditional | PDF ↗ |
| K242195 | Gemini Cervical Fusion Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2024-11-04 | Traditional | PDF ↗ |
| K241738 | PYXIS 3D Titanium Cervical Cage system | GS Medical Co., Ltd. | 2024-08-20 | Traditional | PDF ↗ |
| K240893 | ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical | 2024-06-28 | Traditional | PDF ↗ |
| K240838 | Spectrum Spine Cervical Cage System | Spectrum Spine, Inc. | 2024-05-30 | Traditional | PDF ↗ |
| K241396 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | Ulrich Medical USA, Inc. | 2024-05-23 | Special | PDF ↗ |
| K232619 | MATRIX HA PEEK Cervical IBF System | Sapphire Medical Group | 2024-03-19 | Special | PDF ↗ |
| K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024-03-12 | Special | PDF ↗ |
| K231371 | BEE Cervical Cage | NGMedical GmbH | 2024-01-12 | Traditional | PDF ↗ |
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 2023-12-20 | Special | PDF ↗ |
| K230639 | Align Cervical Interbody Fusion System | Acuity Surgical Devices, LLC | 2023-12-01 | Traditional | PDF ↗ |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 2023-11-21 | Traditional | PDF ↗ |
| K231836 | ClariVy Cervical IBF System | Vy Spine, LLC | 2023-10-30 | Traditional | PDF ↗ |
| K230478 | Acro Composites Interbody System | Acro Composites, LLC | 2023-10-19 | Traditional | PDF ↗ |
| K231899 | HAtetracell-C Titanium Cervical IBF System | Innovasis, Inc. | 2023-10-17 | Traditional | PDF ↗ |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) | Gbs Commonwealth Co., Ltd. | 2023-10-13 | Special | PDF ↗ |
| K231076 | VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. | 2023-09-27 | Traditional | PDF ↗ |
| K222988 | neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical | Ht Medical D.B.A. Xenix Medical | 2023-09-01 | Traditional | PDF ↗ |
| K232150 | ZSFab Cervical Interbody System | Zsfab, Inc. | 2023-08-18 | Special | PDF ↗ |
| K230607 | SPICCA Cervical Fusion Cages | Southern Medical (Pty) , Ltd. | 2023-08-14 | Traditional | PDF ↗ |
| K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | Carbofix Orthpedics , Ltd. | 2023-07-26 | Traditional | PDF ↗ |
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System | Nu Vasive, Incorporated | 2023-07-11 | Special | PDF ↗ |
| K222015 | Integral Titanium Cervical Interbody | Nvision Biomedical Technologies, Inc. | 2023-07-05 | Traditional | PDF ↗ |
| K230329 | F3D Interbody System | Corelink, LLC | 2023-06-06 | Traditional | PDF ↗ |
| K230936 | Anatomic PEEK Cervical Fusion System with Nanotechnology | Nanovis, LLC | 2023-06-02 | Traditional | PDF ↗ |
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) | Gbs Commonwealth Co., Ltd. | 2023-05-22 | Traditional | PDF ↗ |
| K222833 | Ventana C Spinal System | Spinal Elements, Inc. | 2023-05-19 | Traditional | PDF ↗ |
| K230414 | ClariVy Cervical IBF System | Vy Spine, LLC | 2023-05-12 | Special | PDF ↗ |
| K222004 | INTEGRATE -C Interbody Fusion System | Happe Spine | 2023-04-28 | Traditional | PDF ↗ |
| K220513 | NITRO Interbody Fusion Cage System Family | Ctl Medical Corporation | 2023-04-25 | Traditional | PDF ↗ |
| K220261 | NEST-C Interbody System | Paonan Biotech Co., Ltd. | 2023-04-24 | Traditional | PDF ↗ |
| K223513 | UniVy OsteoVy-Ti Cervical IBF System | Vy Spine, LLC | 2023-04-18 | Special | PDF ↗ |
| K230026 | SQUALE | Implanet, S.A. | 2023-03-28 | Traditional | PDF ↗ |
| K230583 | Tryptik Ti | Spineart SA | 2023-03-22 | Special | PDF ↗ |
| K223043 | The Integrity Spine Core System | Integrity Spine | 2023-03-20 | Traditional | PDF ↗ |
| K223231 | Ti-Largo Cervical Interbody System | Flospine | 2023-02-24 | Traditional | PDF ↗ |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 2023-02-17 | Traditional | PDF ↗ |
| K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer | Stryker Spine | 2023-02-14 | Traditional | PDF ↗ |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2023-02-13 | Traditional | PDF ↗ |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion System | Eminent Spine | 2023-02-06 | Traditional | PDF ↗ |
| K220296 | Manta Ray TDF Spacer | SeaSpine Orthopedics Corporation | 2023-02-03 | Traditional | PDF ↗ |
| K223731 | NuVasive Modulus-C Interbody System | Nuvasive, Inc. | 2023-01-12 | Special | PDF ↗ |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion Device | 4Web Medical, Inc. | 2023-01-05 | Traditional | PDF ↗ |
| K222806 | Kodiak C Spinal Implant System | Met One Technologies, LLC | 2022-12-22 | Traditional | PDF ↗ |
| K223510 | Matrix HA Fusion Porous Cervical IBF System | Innovasis, Inc. | 2022-12-12 | Special | PDF ↗ |
| K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem | Alphatec Spine, Inc. | 2022-11-17 | Traditional | PDF ↗ |
| K221162 | UniVy OsteoVy Cervical IBF System | Vy Spine, LLC | 2022-11-04 | Traditional | PDF ↗ |
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments | Globus Medical, Inc. | 2022-10-21 | Traditional | PDF ↗ |
| K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022-10-15 | Traditional | PDF ↗ |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | Innovasis, Inc. | 2022-08-26 | Traditional | PDF ↗ |
| K220696 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | Ulrich Medical USA | 2022-08-19 | Traditional | PDF ↗ |
| K212450 | Keos Anterior Cervical Interbody Fusion Device System | Keos | 2022-06-06 | Traditional | PDF ↗ |
| K202266 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2022-03-29 | Traditional | PDF ↗ |
| K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | 2022-03-15 | Traditional | PDF ↗ |
| K213493 | Fortilink with TiPlus Technology | Paradigm Spine | 2022-01-27 | Traditional | PDF ↗ |
| K212266 | FIX-C PEEK Anterior Cervical Interbody System | Jeil Medical Corporation | 2021-12-21 | Traditional | PDF ↗ |
| K212715 | Vy Spine ClariVy Cervical IBF System | Vy Spine, LLC | 2021-12-20 | Traditional | PDF ↗ |
| K213115 | CHENA-C Spacer System | Kahtnu Surgical, Inc. | 2021-12-06 | Special | PDF ↗ |
| K211935 | ORIO-Ti Intervertebral Body Fusion Cage System | Spinecraft, LLC | 2021-09-30 | Traditional | PDF ↗ |
| K212792 | Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | Medynus, Inc. | 2021-09-23 | Traditional | PDF ↗ |
| K201793 | EDEN Peek Cage | Jmt Co., Ltd. | 2021-09-13 | Traditional | PDF ↗ |
| K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System | Orthofix, Inc. | 2021-08-31 | Traditional | PDF ↗ |
| K212038 | K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | K&J Consulting Corporation | 2021-08-27 | Traditional | PDF ↗ |
| K211501 | Advantage-C PEEK Cervical lnterbody Fusion Device | Lntelivation, LLC | 2021-08-24 | Traditional | PDF ↗ |
| K210521 | DEXA-C Cervical Interbody System | Aurora Spine, Inc. | 2021-08-02 | Traditional | PDF ↗ |
| K210890 | GPS Cervical Spacers | G Surgical, LLC | 2021-04-23 | Special | PDF ↗ |
| K203520 | Blustone Synergy Interbody Fusion System | Blustone Synergy, LLC | 2021-04-07 | Traditional | PDF ↗ |
| K203444 | BEE HA Cage | NGMedical GmbH | 2021-03-18 | Traditional | PDF ↗ |
| K203342 | CONSTRUX Mini Ti Spacer System | Orthofix, Inc. | 2021-03-18 | Traditional | PDF ↗ |
Product code ODP · Class II · Orthopedic. Data: openFDA.