RESTORATION HA ACETABULAR CUP SERIES— 510(k) K943957

Name: FDA 510(k) clearance K943957
Creator: U.S. Food and Drug Administration
Published: 1995-03-06

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.. Device class: 2.

Clearance details

Applicant: Osteonics Corp.
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
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

Download summary PDF View on FDA.gov ↗

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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.