OSTEONICS EXTENDED FEMORAL BEARING HEAD— 510(k) K982936

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K982936 for OSTEONICS EXTENDED FEMORAL BEARING HEAD, Substantially Equivalent on 1998-10-21. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 1998-08-21
Decision date: 1998-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.