OSTEONICS OMNIFIT FORGED HIP STEM SERIES— 510(k) K933561

Substantially Equivalent for Some Indications

Osteonics Corp.

FDA 510(k) clearance K933561 for OSTEONICS OMNIFIT FORGED HIP STEM SERIES, Substantially Equivalent for Some Indications on 1994-03-09. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1993-07-22
Decision date: 1994-03-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.