ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT— 510(k) K121636

Substantially Equivalent

Tgm Medical, Inc.

FDA 510(k) clearance K121636 for ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT, Substantially Equivalent on 2012-10-24. Applicant: Tgm Medical, Inc..

Clearance details

Applicant: Tgm Medical, Inc.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2012-06-04
Decision date: 2012-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado Hills, CA, US

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.