RESTORATION HA ACETABULAR CUP SERIES— 510(k) K943957

Substantially Equivalent for Some Indications

Osteonics Corp.

FDA 510(k) clearance K943957 for RESTORATION HA ACETABULAR CUP SERIES, Substantially Equivalent for Some Indications on 1995-03-06. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 1994-08-15
Decision date: 1995-03-06
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Allendale, 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.