ClearanceBrief
Panels › Orthopedic › Product code ODP · Class 2

Intervertebral Fusion Device With Bone Graft, Cervical

Regulation 888.3080

24510(k)s in 12 months (354 all time)
2recalls in 12 months (11 all time)
9recalls that name a 510(k)
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Top companies in ODP

Company510(k)sRecalls
Medtronic Sofamor Danek100
Orthofix100
Nu Vasive, Incorporated80
Gbs Commonwealth Co., Ltd.70
Globus Medical, Inc.70
Reliance Medical Systems, LLC60
Spineart60
Stryker Spine60
Innovasis, Inc.50
L&K BIOMED Co., Ltd.50
Decided510(k)Device and applicantCode
Aug 26, 2026K262595VariLift-C Cervical Interbody Fusion System
Wenzel Spine, Inc.
ODP
Aug 18, 2026K262489BluEX Cervical Expandable Cage System
L&K BIOMED Co., Ltd., KR
ODP
Jul 23, 2026K2530413d Cage Cervical
Fims Co., Ltd., KR
ODP
Jul 17, 2026K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical C
Stryker Spine
ODP
Jul 8, 2026K254130C.A. Medical Interbody Fusion System
C.A. Medical, LLC
ODP
May 16, 2026K260840BluEX Cervical Expandable Cage System
L&K BIOMED Co., Ltd., KR
ODP
May 12, 2026K260850OSTEOMNI SPINAL CAGES SYSTEM
Osteomni, Inc.
ODP
Apr 24, 2026K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
Zsfab, Inc.
ODP
Apr 16, 2026K253260ORIO-3D Cage System
SpineCraft
ODP
Apr 13, 2026K260340HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAG
HC Biologics, LLC
ODP
Apr 1, 2026K242303MOD-C
Orthomod, LLC
ODP
Mar 30, 2026K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
Spectrum Spine
ODP
Mar 25, 2026K252432Flex-Z™ Cervical Cage
Spinepoint, LLC
ODP
Feb 13, 2026K254105Hive™ Standalone Cervical System and Hive™ C Interbody System
NanoHive Medical, LLC
ODP
Jan 16, 2026K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Lamin
Curiteva, Inc.
ODP
Jan 15, 2026K254061Curiteva Porous PEEK Cervical Interbody Fusion System
Curiteva, Inc.
ODP
Jan 14, 2026K252219Cervical Interbody and VBR Fusion System
Sync Surgical
ODP
Jan 8, 2026K252711Advantage-C™ Ti3D Cervical Interbody Fusion Device
Intelivation Technologies
ODP
Jan 6, 2026K252894aprevo® cervical interbody system
Carlsmed, Inc.
ODP
Dec 19, 2025K252781MSFX MIKRON PEEK CAGES
Mikron Makina Sanayi VE Tic. Ltd. Sti., TR
ODP
Dec 5, 2025K250764SpineLinc Anterior Cervical Implant System
Lincotek Medical
ODP
Nov 24, 2025K250769Dakota LP System
Precision Spine, Inc.
ODP
Nov 21, 2025K252686EffortMed PEEK Cages & Corpectomy Cages
Effortmed, LLC
ODP
Nov 21, 2025K250560BEE HA
NGMedical GmbH, DE
ODP
Oct 10, 2025K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion System
Degen Medical
ODP
Aug 29, 2025K250335IVA & AEON Cervical and Lumbar Cage System
K&J Consulting
ODP
Jul 3, 2025K251080IdentiTi II Cervical Interbody System
Alphatec Spine, Inc.
ODP
Mar 12, 2025K250605EVOL® ha – Hyper C Cervical Interbody Fusion System
Cutting Edge Spine, LLC
ODP
Feb 18, 2025K243915FIX-C 3D Ti ACIF System
Jeil Medical Corporation, KR
ODP
Jan 29, 2025K243673Xenco Medical CancelleX Cervical Interbody System
Xenco Medical, LLC
ODP
Nov 15, 2024K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM
Carlsmed, Inc.
ODP
Nov 7, 2024K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System
Zsfab
ODP
Nov 4, 2024K242195Gemini Cervical Fusion Cage System
ZheJiang Decans Medical Devices Co., Ltd., CN
ODP
Aug 20, 2024K241738PYXIS 3D Titanium Cervical Cage system
GS Medical Co., Ltd., KR
ODP
Jun 28, 2024K240893ARTFX MEDICAL Cervical PEEK Cages
Artfx Medical
ODP
May 30, 2024K240838Spectrum Spine Cervical Cage System
Spectrum Spine, Inc.
ODP
May 23, 2024K241396uCerv Flux™-C 3D Porous Titanium Cervical Interbody
Ulrich Medical USA, Inc.
ODP
Mar 19, 2024K232619MATRIX HA PEEK Cervical IBF System
Sapphire Medical Group
ODP
Mar 12, 2024K240416Tranquil-C Interbody System
Nexus Spine, LLC
ODP
Jan 12, 2024K231371BEE Cervical Cage
NGMedical GmbH, DE
ODP
Dec 20, 2023K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Perido
Gbs Commonwealth Co., Ltd., KR
ODP
Dec 1, 2023K230639Align Cervical Interbody Fusion System
Acuity Surgical Devices, LLC
ODP
Nov 21, 2023K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
Gbs Commonwealth Co., Ltd., KR
ODP
Oct 30, 2023K231836ClariVy™ Cervical IBF System
Vy Spine, LLC
ODP
Oct 19, 2023K230478Acro Composites Interbody System
Acro Composites, LLC
ODP
Oct 17, 2023K231899HAtetracell™-C Titanium Cervical IBF System
Innovasis, Inc.
ODP
Oct 13, 2023K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (
Gbs Commonwealth Co., Ltd., KR
ODP
Sep 27, 2023K231076VariLift®-C Interbody Fusion System
Wenzel Spine, Inc.
ODP
Sep 1, 2023K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
Ht Medical D.B.A. Xenix Medical
ODP
Aug 18, 2023K232150ZSFab Cervical Interbody System
Zsfab, Inc.
ODP

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