DeGen Medical Patient Specific Implant (PSI) System— 510(k) K241077

Substantially Equivalent

Degen Medical

FDA 510(k) clearance K241077 for DeGen Medical Patient Specific Implant (PSI) System, Substantially Equivalent on 2024-10-29. Applicant: Degen Medical.

Clearance details

Applicant: Degen Medical
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2024-04-19
Decision date: 2024-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Florence, SC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.