PROSTHESIS, HIP FEMORAL COMPONENT METAL— 510(k) K803191

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K803191 for PROSTHESIS, HIP FEMORAL COMPONENT METAL, Substantially Equivalent on 1981-01-23. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1980-12-16
Decision date: 1981-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.