TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT— 510(k) K121509

Substantially Equivalent

Tgm Medical, Inc.

FDA 510(k) clearance K121509 for TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT, Substantially Equivalent on 2012-11-05. Applicant: Tgm Medical, Inc..

Clearance details

Applicant: Tgm Medical, Inc.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2012-05-21
Decision date: 2012-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado, CA, US

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Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.