MECRON(R) ACETABULAR NETS TM— 510(k) K820619

Substantially Equivalent

Serrano Intl.

FDA 510(k) clearance K820619 for MECRON(R) ACETABULAR NETS TM, Substantially Equivalent on 1982-05-14. Applicant: Serrano Intl..

Clearance details

Applicant: Serrano Intl.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 1982-03-08
Decision date: 1982-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.