ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)— 510(k) K951139

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K951139 for ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL), Substantially Equivalent on 1995-11-22. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1995-03-13
Decision date: 1995-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

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Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.