Cleared Traditional

Solar Lumbar Interbody Fusion System

K231199 · Degen Medical · Orthopedic

Jun 2023

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K231199 is an FDA 510(k) clearance for the Solar Lumbar Interbody Fusion System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Degen Medical (Florence, US). The FDA issued a Cleared decision on June 16, 2023, 50 days after receiving the submission on April 27, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K231199 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 27, 2023
Decision Date	June 16, 2023
Days to Decision	50 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.