COLLAGEN TENDON WRAP— 510(k) K080452

Name: FDA 510(k) clearance K080452
Creator: U.S. Food and Drug Administration
Published: 2008-05-15

Substantially Equivalent

Collagen Matrix, Inc.

FDA 510(k) clearance K080452 for COLLAGEN TENDON WRAP, Substantially Equivalent on 2008-05-15. Applicant: Collagen Matrix, Inc.. Device class: 2.

Clearance details

Applicant: Collagen Matrix, Inc.
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2008-02-19
Decision date: 2008-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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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.