PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF— 510(k) K112786

Name: FDA 510(k) clearance K112786
Creator: U.S. Food and Drug Administration
Published: 2011-10-25

Substantially Equivalent

Synovis Orthopedic and Woundcare, Inc.

FDA 510(k) clearance K112786 for PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF, Substantially Equivalent on 2011-10-25. Applicant: Synovis Orthopedic and Woundcare, Inc.. Device class: 2.

Clearance details

Applicant: Synovis Orthopedic and Woundcare, Inc.
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2011-09-26
Decision date: 2011-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K243595 — OviTex PRS (Long-Term Resorbable)2024-12-19
K233991 — CanGaroo RM Antibacterial Envelope2024-06-14
K241126 — OviTex PRS2024-05-22

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.