ENDOFORM RECONSTRUCTIVE TEMPLATE— 510(k) K130547

Substantially Equivalent

Mesynthe, Ltd.

FDA 510(k) clearance K130547 for ENDOFORM RECONSTRUCTIVE TEMPLATE, Substantially Equivalent on 2013-05-31. Applicant: Mesynthe, Ltd..

Clearance details

Applicant: Mesynthe, Ltd.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2013-03-04
Decision date: 2013-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.