Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ODP · Predicate Candidate Screening
352 FDA 510(k) clearances under this product code; the 50 most recent screened below.
117 daysmedian FDA review time
273 days90th percentile
352clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253041 | 3d Cage Cervical | Fims Co., Ltd. | 2026-07-23 | 304 | 0 |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tri | Stryker Spine | 2026-07-17 | 29 | 0 |
| K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | 2026-07-08 | 198 | 0 |
| K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026-05-16 | 61 | 0 |
| K260850 | OSTEOMNI SPINAL CAGES SYSTEM | Osteomni, Inc. | 2026-05-12 | 57 | 0 |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody S | Zsfab, Inc. | 2026-04-24 | 65 | 0 |
| K253260 | ORIO-3D Cage System | SpineCraft | 2026-04-16 | 199 | 0 |
| K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT | HC Biologics, LLC | 2026-04-13 | 70 | 0 |
| K242303 | MOD-C | Orthomod, LLC | 2026-04-01 | 604 | 0 |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar C | Spectrum Spine | 2026-03-30 | 256 | 0 |
| K252432 | Flex-Z™ Cervical Cage | Spinepoint, LLC | 2026-03-25 | 236 | 0 |
| K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody Syste | NanoHive Medical, LLC | 2026-02-13 | 56 | 0 |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Por | Curiteva, Inc. | 2026-01-16 | 186 | 0 |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2026-01-15 | 29 | 0 |
| K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | 2026-01-14 | 183 | 0 |
| K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | 2026-01-08 | 134 | 0 |
| K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026-01-06 | 117 | 0 |
| K252781 | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. | 2025-12-19 | 108 | 0 |
| K250764 | SpineLinc Anterior Cervical Implant System | Lincotek Medical | 2025-12-05 | 267 | 0 |
| K250769 | Dakota LP System | Precision Spine, Inc. | 2025-11-24 | 256 | 0 |
| K250560 | BEE HA | NGMedical GmbH | 2025-11-21 | 269 | 0 |
| K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | 2025-11-21 | 87 | 0 |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Degen Medical | 2025-10-10 | 43 | 0 |
| K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | 2025-08-29 | 205 | 0 |
| K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | 2025-07-03 | 86 | 0 |
| K250605 | EVOL® ha – Hyper C Cervical Interbody Fusion System | Cutting Edge Spine, LLC | 2025-03-12 | 12 | 0 |
| K243915 | FIX-C 3D Ti ACIF System | Jeil Medical Corporation | 2025-02-18 | 60 | 0 |
| K243673 | Xenco Medical CancelleX Cervical Interbody System | Xenco Medical, LLC | 2025-01-29 | 63 | 0 |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cerv | Carlsmed, Inc. | 2024-11-15 | 107 | 0 |
| K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody Syst | Zsfab | 2024-11-07 | 58 | 0 |
| K242195 | Gemini Cervical Fusion Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2024-11-04 | 101 | 0 |
| K241738 | PYXIS 3D Titanium Cervical Cage system | GS Medical Co., Ltd. | 2024-08-20 | 64 | 0 |
| K240893 | ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical | 2024-06-28 | 88 | 0 |
| K240838 | Spectrum Spine Cervical Cage System | Spectrum Spine, Inc. | 2024-05-30 | 64 | 0 |
| K241396 | uCerv Flux™-C 3D Porous Titanium Cervical Interbody | Ulrich Medical USA, Inc. | 2024-05-23 | 7 | 0 |
| K232619 | MATRIX HA PEEK Cervical IBF System | Sapphire Medical Group | 2024-03-19 | 203 | 0 |
| K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024-03-12 | 29 | 0 |
| K231371 | BEE Cervical Cage | NGMedical GmbH | 2024-01-12 | 245 | 0 |
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion Syst | Gbs Commonwealth Co., Ltd. | 2023-12-20 | 16 | 0 |
| K230639 | Align Cervical Interbody Fusion System | Acuity Surgical Devices, LLC | 2023-12-01 | 268 | 0 |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion Syst | Gbs Commonwealth Co., Ltd. | 2023-11-21 | 56 | 0 |
| K231836 | ClariVy™ Cervical IBF System | Vy Spine, LLC | 2023-10-30 | 130 | 0 |
| K230478 | Acro Composites Interbody System | Acro Composites, LLC | 2023-10-19 | 239 | 0 |
| K231899 | HAtetracell™-C Titanium Cervical IBF System | Innovasis, Inc. | 2023-10-17 | 111 | 0 |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body | Gbs Commonwealth Co., Ltd. | 2023-10-13 | 30 | 0 |
| K231076 | VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. | 2023-09-27 | 166 | 0 |
| K222988 | neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cer | Ht Medical D.B.A. Xenix Medical | 2023-09-01 | 338 | 0 |
| K232150 | ZSFab Cervical Interbody System | Zsfab, Inc. | 2023-08-18 | 30 | 0 |
| K230607 | SPICCA Cervical Fusion Cages | Southern Medical (Pty) , Ltd. | 2023-08-14 | 164 | 0 |
| K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR Sys | Carbofix Orthpedics , Ltd. | 2023-07-26 | 307 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda