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

Name: FDA 510(k) clearance K091142
Creator: U.S. Food and Drug Administration
Published: 2009-08-31

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.. Device class: 2.

Clearance details

Applicant: Rti Biologics, Inc.
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
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

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTM

view all

K262406 — EluPro Antibiotic-Eluting BioEnvelope2026-08-12
K250598 — Endoform Reconstructive Template - PLGA2025-06-03
K243595 — OviTex PRS (Long-Term Resorbable)2024-12-19
K233991 — CanGaroo RM Antibacterial Envelope2024-06-14
K241126 — OviTex PRS2024-05-22

More clearances from Rti Biologics, Inc.

view all

K123356 — FORTIVA PORCINE DERMIS2013-03-05
K081538 — TUTOPATCH, TUTOMESH2008-06-19

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.