TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358— 510(k) K091142

Substantially Equivalent

Rti Biologics, Inc.

FDA 510(k) clearance K091142 for TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358, Substantially Equivalent on 2009-08-31. Applicant: Rti Biologics, Inc..

Clearance details

Applicant: Rti Biologics, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2009-04-20
Decision date: 2009-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Alachua, FL, US

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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.