SIS FACIAL CYLINDER, SIS FACIAL IMPLANT— 510(k) K070738

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K070738 for SIS FACIAL CYLINDER, SIS FACIAL IMPLANT, Substantially Equivalent on 2007-04-05. Applicant: Cook Biotech, Inc..

Clearance details

Applicant: Cook Biotech, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2007-03-16
Decision date: 2007-04-05
Decision: Substantially Equivalent
Clearance type: Special
Location: West Lafayette, IN, 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.