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ODP

Intervertebral Fusion Device With Bone Graft, Cervical

Product code
ODP
Device name
Intervertebral Fusion Device With Bone Graft, Cervical
Device class
Class 2
21 CFR
21 CFR 888.3080
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
354

FDA classification definition

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (48)

Last three years. Most recent: 2026-08-26.

NumberDecision dateApplicantDevice nameSummary
K2625952026-08-26Wenzel Spine, Inc.VariLift-C Cervical Interbody Fusion SystemPDF
K2624892026-08-18L&K BIOMED Co., Ltd.BluEX Cervical Expandable Cage SystemFDA
K2530412026-07-23Fims Co., Ltd.3d Cage CervicalPDF
K2620612026-07-17Stryker SpineTritanium® C Anterior Cervical Cage; Tritanium® PL CPDF
K2541302026-07-08C.A. Medical, LLCC.A. Medical Interbody Fusion SystemPDF
K2608402026-05-16L&K BIOMED Co., Ltd.BluEX Cervical Expandable Cage SystemFDA
K2608502026-05-12Osteomni, Inc.OSTEOMNI SPINAL CAGES SYSTEMPDF
K2605492026-04-24Zsfab, Inc.ZSFab Cervical Interbody System and ZSFab Lumbar IntPDF
K2532602026-04-16SpineCraftORIO-3D Cage SystemPDF
K2603402026-04-13HC Biologics, LLCHC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTPDF
K2423032026-04-01Orthomod, LLCMOD-CPDF
K2522402026-03-30Spectrum SpineSpectrum Spine Cervical Cage System; Spectrum Spine PDF
K2524322026-03-25Spinepoint, LLCFlex-Z™ Cervical CagePDF
K2541052026-02-13NanoHive Medical, LLCHive™ Standalone Cervical System and Hive™ C InterboPDF
K2522052026-01-16Curiteva, Inc.Curiteva Porous PEEK Cervical Interbody System; CuriPDF
K2540612026-01-15Curiteva, Inc.Curiteva Porous PEEK Cervical Interbody Fusion SystePDF
K2522192026-01-14Sync SurgicalCervical Interbody and VBR Fusion SystemPDF
K2527112026-01-08Intelivation TechnologiesAdvantage-C™ Ti3D Cervical Interbody Fusion DevicePDF
K2528942026-01-06Carlsmed, Inc.aprevo® cervical interbody systemFDA
K2527812025-12-19Mikron Makina Sanayi VE Tic. Ltd. Sti.MSFX MIKRON PEEK CAGESPDF
K2507642025-12-05Lincotek MedicalSpineLinc Anterior Cervical Implant SystemPDF
K2507692025-11-24Precision Spine, Inc.Dakota LP SystemPDF
K2526862025-11-21Effortmed, LLCEffortMed PEEK Cages & Corpectomy CagesPDF
K2505602025-11-21NGMedical GmbHBEE HAPDF
K2527372025-10-10Degen MedicalDeGen Medical Latitude-C AM Cervical Interbody FusioPDF
K2503352025-08-29K&J ConsultingIVA & AEON Cervical and Lumbar Cage SystemPDF
K2510802025-07-03Alphatec Spine, Inc.IdentiTi II Cervical Interbody SystemFDA
K2506052025-03-12Cutting Edge Spine, LLCEVOL® ha – Hyper C Cervical Interbody Fusion SystemPDF
K2439152025-02-18Jeil Medical CorporationFIX-C 3D Ti ACIF SystemPDF
K2436732025-01-29Xenco Medical, LLCXenco Medical CancelleX Cervical Interbody SystemPDF
K2422602024-11-15Carlsmed, Inc.aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprePDF
K2427342024-11-07ZsfabZSFab Cervical Interbody System; ZSFab Lumbar InterbPDF
K2421952024-11-04ZheJiang Decans Medical Devices Co., LGemini Cervical Fusion Cage SystemPDF
K2417382024-08-20GS Medical Co., Ltd.PYXIS 3D Titanium Cervical Cage systemPDF
K2408932024-06-28Artfx MedicalARTFX MEDICAL Cervical PEEK CagesPDF
K2408382024-05-30Spectrum Spine, Inc.Spectrum Spine Cervical Cage SystemPDF
K2413962024-05-23Ulrich Medical USA, Inc.uCerv Flux™-C 3D Porous Titanium Cervical InterbodyPDF
K2326192024-03-19Sapphire Medical GroupMATRIX HA PEEK Cervical IBF SystemPDF
K2404162024-03-12Nexus Spine, LLCTranquil-C Interbody SystemPDF
K2313712024-01-12NGMedical GmbHBEE Cervical CagePDF
K2338392023-12-20Gbs Commonwealth Co., Ltd.Peridot-PT Anterior Cervical Intervertebral body fusPDF
K2306392023-12-01Acuity Surgical Devices, LLCAlign Cervical Interbody Fusion SystemPDF
K2330842023-11-21Gbs Commonwealth Co., Ltd.Peridot-PT Anterior Cervical Intervertebral body fusPDF
K2318362023-10-30Vy Spine, LLCClariVy™ Cervical IBF SystemPDF
K2304782023-10-19Acro Composites, LLCAcro Composites Interbody SystemPDF
K2318992023-10-17Innovasis, Inc.HAtetracell™-C Titanium Cervical IBF SystemFDA
K2328222023-10-13Gbs Commonwealth Co., Ltd.Peridot-TD Spacer system (The Peridot-TD IntervertebPDF
K2310762023-09-27Wenzel Spine, Inc.VariLift®-C Interbody Fusion SystemPDF

43 summaries are archived here for direct download.

Official FDA classification page: ODP
Classification and pathway per current FDA publications. Data from openFDA (CC0).