510(k) K110581— PROPATCH SOFT TISSUE REPAIR MATRIX

Substantially Equivalent

Cryolife, Inc.

Clearance details

Applicant: Cryolife, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2011-03-01
Decision date: 2012-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, US

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.