DeGen Medical Patient Specific Implant (PSI) System— 510(k) K250667

Name: FDA 510(k) clearance K250667
Creator: U.S. Food and Drug Administration
Published: 2025-04-04

Substantially Equivalent

Degen Medical

FDA 510(k) clearance K250667 for DeGen Medical Patient Specific Implant (PSI) System, Substantially Equivalent on 2025-04-04. Applicant: Degen Medical. Device class: 2.

Clearance details

Applicant: Degen Medical
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-03-05
Decision date: 2025-04-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Florence, SC, US

Download summary PDF View on FDA.gov ↗

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K231199 — Solar Lumbar Interbody Fusion System2023-06-16
K223418 — DeGen Impulse AM System2023-03-17

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.