PRO-FEMUR R— 510(k) K003016

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K003016 for PRO-FEMUR R, Substantially Equivalent on 2000-12-13. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 2000-09-27
Decision date: 2000-12-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arlington, TN, 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.