Hive Standalone Cervical System and Hive C Interbody System— 510(k) K254105
Substantially EquivalentNanoHive Medical, LLC
FDA 510(k) clearance K254105 for Hive Standalone Cervical System and Hive C Interbody System, Substantially Equivalent on 2026-02-13. Applicant: NanoHive Medical, LLC. Device class: 2.
Summary
NanoHive Medical's record names the Hive Standalone Cervical System and the Hive C Interbody System under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical). The record doesn't describe either one beyond its name and that code name.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
NanoHive Medical filed from Woburn, Massachusetts. Review took 56 calendar days (December 19, 2025 to February 13, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- NanoHive Medical, LLC
- Product code
- Product code ODP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woburn, MA, US
Recent devices under product code ODP
view allMore clearances from NanoHive Medical, LLC
view allAdverse events under product code ODP
product code ODP- Injury
- 310
- Total
- 310
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.