OSTEONICS RESTORATION MONOLITHIC HIP STEM— 510(k) K943774

Substantially Equivalent for Some Indications

Osteonics Corp.

FDA 510(k) clearance K943774 for OSTEONICS RESTORATION MONOLITHIC HIP STEM, Substantially Equivalent for Some Indications on 1995-03-06. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1994-08-02
Decision date: 1995-03-06
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.