Cleared Traditional

Hive? Standalone Cervical System and Hive? C Interbody System

K254105 · NanoHive Medical, LLC · Orthopedic

Feb 2026

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K254105 is an FDA 510(k) clearance for the Hive? Standalone Cervical System and Hive? C Interbody System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by NanoHive Medical, LLC (Woburn, US). The FDA issued a Cleared decision on February 13, 2026, 56 days after receiving the submission on December 19, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K254105 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2025
Decision Date	February 13, 2026
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.