Chrysalis Intelligence · Product Codes · ODP

ODP · Intervertebral Fusion Device With Bone Graft, Cervical

Orthopedic · 116 clearances · 83 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Device class
Class II
Regulation 888.3080
Total clearances
116
2020-01-03 → 2026-07-23
Last 12 months
24
Unique sponsors
83
Definition

What is Intervertebral Fusion Device With Bone Graft, Cervical

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Classification details
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3080
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Gbs Commonwealth Co., Ltd. 7 0 2023-12-20
Orthofix, Inc. 5 0 2021-08-31
Vy Spine, LLC 5 0 2023-10-30
NGMedical GmbH 4 1 2025-11-21
Zsfab, Inc. 4 1 2026-04-24
Innovasis, Inc. 3 0 2023-10-17
Curiteva, Inc. 3 2 2026-01-16
Stryker Spine 2 1 2026-07-17
K&J Consulting Corporation 2 1 2025-08-29
Ulrich Medical USA, Inc. 2 0 2024-05-23
Spectrum Spine, Inc. 2 1 2026-03-30
Jeil Medical Corporation 2 0 2025-02-18
Carlsmed, Inc. 2 1 2026-01-06
GS Medical Co., Ltd. 2 0 2024-08-20
Alphatec Spine, Inc. 2 0 2025-07-03
SpineCraft 2 1 2026-04-16
Choice Spine, LLC 1 0 2020-12-22
Artfx Medical 1 0 2024-06-28
Wenzel Spine, Inc. 1 0 2023-09-27
4Web Medical, Inc. 1 0 2023-01-05
Integrity Spine 1 0 2023-03-20
Lucero Medical, LLC 1 0 2020-12-16
Nuvasive, Inc. 1 0 2023-01-12
Spinal Elements, Inc. 1 0 2023-05-19
Happe Spine 1 0 2023-04-28
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
22554 CPT — High Anterior cervical discectomy and fusion with bone graft standard code
22600 CPT — Medium Arthrodesis, posterior approach cervical spine with bone graft
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-23 K253041 Fims Co., Ltd. 3d Cage Cervical
2026-07-17 K262061 Stryker Spine 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
2026-07-08 K254130 C.A. Medical, LLC C.A. Medical Interbody Fusion System
2026-05-16 K260840 L&K BIOMED Co., Ltd. BluEX Cervical Expandable Cage System
2026-05-12 K260850 Osteomni, Inc. OSTEOMNI SPINAL CAGES SYSTEM
2026-04-24 K260549 Zsfab, Inc. ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
2026-04-16 K253260 SpineCraft ORIO-3D Cage System
2026-04-13 K260340 HC Biologics, LLC HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
2026-04-01 K242303 Orthomod, LLC MOD-C
2026-03-30 K252240 Spectrum Spine Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
2026-03-25 K252432 Spinepoint, LLC Flex-Z™ Cervical Cage
2026-02-13 K254105 NanoHive Medical, LLC Hive™ Standalone Cervical System and Hive™ C Interbody System
2026-01-16 K252205 Curiteva, Inc. Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System
2026-01-15 K254061 Curiteva, Inc. Curiteva Porous PEEK Cervical Interbody Fusion System
2026-01-14 K252219 Sync Surgical Cervical Interbody and VBR Fusion System
2026-01-08 K252711 Intelivation Technologies Advantage-C™ Ti3D Cervical Interbody Fusion Device
2026-01-06 K252894 Carlsmed, Inc. aprevo® cervical interbody system
2025-12-19 K252781 Mikron Makina Sanayi VE Tic. Ltd. Sti. MSFX MIKRON PEEK CAGES
2025-12-05 K250764 Lincotek Medical SpineLinc Anterior Cervical Implant System
2025-11-24 K250769 Precision Spine, Inc. Dakota LP System
2025-11-21 K252686 Effortmed, LLC EffortMed PEEK Cages & Corpectomy Cages
2025-11-21 K250560 NGMedical GmbH BEE HA
2025-10-10 K252737 Degen Medical DeGen Medical Latitude-C AM Cervical Interbody Fusion System
2025-08-29 K250335 K&J Consulting IVA & AEON Cervical and Lumbar Cage System
2025-07-03 K251080 Alphatec Spine, Inc. IdentiTi II Cervical Interbody System
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence