ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD— 510(k) K111936

Substantially Equivalent

Ortho Development

FDA 510(k) clearance K111936 for ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD, Substantially Equivalent on 2011-09-21. Applicant: Ortho Development.

Clearance details

Applicant: Ortho Development
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2011-07-08
Decision date: 2011-09-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Draper, UT, 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.