MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)— 510(k) K091499

Name: FDA 510(k) clearance K091499
Creator: U.S. Food and Drug Administration
Published: 2009-10-22

Substantially Equivalent

Kensey Nash Corp.

FDA 510(k) clearance K091499 for MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY), Substantially Equivalent on 2009-10-22. Applicant: Kensey Nash Corp.. Device class: 2.

Clearance details

Applicant: Kensey Nash Corp.
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2009-05-21
Decision date: 2009-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exton, PA, US

Download summary PDF View on FDA.gov ↗

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K090919 — KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE2009-10-02
K073519 — QUICKCAT EXTRACTION CATHETER, MODEL 60090-012008-03-28
K071695 — KENSEY NASH MACROPORE SHIELD2007-12-31

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.