POLYFORM SYNTHETIC MESH— 510(k) K051245

Substantially Equivalent

Proxy Biomedical , Ltd.

FDA 510(k) clearance K051245 for POLYFORM SYNTHETIC MESH, Substantially Equivalent on 2005-06-17. Applicant: Proxy Biomedical , Ltd..

Clearance details

Applicant: Proxy Biomedical , Ltd.
Product code: Code OTO
Advisory panel: General, Plastic Surgery
Date received: 2005-05-16
Decision date: 2005-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTO

product code OTO

Injury: 840
Total: 840

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.