K254105
- 510(k) number
- K254105
- Device name
- Hive Standalone Cervical System and Hive C Interbody System
- Applicant
- NanoHive Medical, LLC MA · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2026-02-13
- Date received
- 2025-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K254105.pdf
Official FDA record: K254105
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.