OSTEONICS(R) THREADED HA ACETABULAR SHELLS— 510(k) K945691

Substantially Equivalent for Some Indications

Osteonics Corp.

FDA 510(k) clearance K945691 for OSTEONICS(R) THREADED HA ACETABULAR SHELLS, Substantially Equivalent for Some Indications on 1995-03-17. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 1994-11-21
Decision date: 1995-03-17
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.