Cleared Traditional

NanoHive Medical Lumbar Interbody System

K231241 · NanoHive Medical, LLC · Orthopedic

Jul 2023

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K231241 is an FDA 510(k) clearance for the NanoHive Medical Lumbar Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by NanoHive Medical, LLC (Woburn, US). The FDA issued a Cleared decision on July 12, 2023, 75 days after receiving the submission on April 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K231241 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2023
Decision Date	July 12, 2023
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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