BIPOLATOR 50— 510(k) K874779

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K874779 for BIPOLATOR 50, Substantially Equivalent on 1988-01-29. Applicant: Treace Medical, Inc..

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1987-11-19
Decision date: 1988-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.