CORMET CEMENTLESS RESURFACING FEMORAL HEAD— 510(k) K092198

Substantially Equivalent

Corin USA

FDA 510(k) clearance K092198 for CORMET CEMENTLESS RESURFACING FEMORAL HEAD, Substantially Equivalent on 2010-04-15. Applicant: Corin USA.

Clearance details

Applicant: Corin USA
Product code: Code KXA
Advisory panel: Orthopedic
Date received: 2009-07-21
Decision date: 2010-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KXA

product code KXA

Injury: 324
Total: 324

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.