TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM— 510(k) K994366

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K994366 for TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM, Substantially Equivalent on 2000-03-16. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 1999-12-27
Decision date: 2000-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

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Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.