ZIMMER COLLAGEN REPAIR PATCH— 510(k) K053562

Substantially Equivalent

Tissue Science Laboratories, Plc

FDA 510(k) clearance K053562 for ZIMMER COLLAGEN REPAIR PATCH, Substantially Equivalent on 2006-06-23. Applicant: Tissue Science Laboratories, Plc.

Clearance details

Applicant: Tissue Science Laboratories, Plc
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2005-12-21
Decision date: 2006-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.