OSTEONICS OMNIFIT AD HIP STEM SERIES— 510(k) K940715

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K940715 for OSTEONICS OMNIFIT AD HIP STEM SERIES, Substantially Equivalent on 1995-06-07. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 1994-02-18
Decision date: 1995-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.