PROFEMUR Z REVISION HIP STEM— 510(k) K121221

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K121221 for PROFEMUR Z REVISION HIP STEM, Substantially Equivalent on 2012-08-09. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2012-04-23
Decision date: 2012-08-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Arlington, TN, 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.