Cleared Traditional

Hive? Standalone Cervical System

K223190 · NanoHive Medical, LLC · Orthopedic

Dec 2022

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K223190 is an FDA 510(k) clearance for the Hive? Standalone Cervical System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by NanoHive Medical, LLC (Woburn, US). The FDA issued a Cleared decision on December 12, 2022, 60 days after receiving the submission on October 13, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K223190 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 13, 2022
Decision Date	December 12, 2022
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.