Cleared Special

K250667 - DeGen Medical Patient Specific Implant (PSI) System
(FDA 510(k) Clearance)

K250667 · Degen Medical · Orthopedic

Apr 2025

Decision

30d

Days

Class 2

Risk

K250667 is an FDA 510(k) clearance for the DeGen Medical Patient Specific Implant (PSI) 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 April 4, 2025, 30 days after receiving the submission on March 5, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K250667 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2025
Decision Date	April 04, 2025
Days to Decision	30 days
Submission Type	Special
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.