CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS— 510(k) K994153

Substantially Equivalent

Corin USA

FDA 510(k) clearance K994153 for CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS, Substantially Equivalent on 2000-02-25. Applicant: Corin USA.

Clearance details

Applicant: Corin USA
Product code: Code KXA
Advisory panel: Orthopedic
Date received: 1999-12-08
Decision date: 2000-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

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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.