OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT— 510(k) K890197

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K890197 for OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT, Substantially Equivalent on 1989-04-07. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code KWZ
Advisory panel: Orthopedic
Date received: 1989-01-17
Decision date: 1989-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code KWZ

product code KWZ

Injury: 993
Total: 993

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.