OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES— 510(k) K946234

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K946234 for OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES, Substantially Equivalent on 1995-04-10. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 1994-12-22
Decision date: 1995-04-10
Decision: Substantially Equivalent
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.