EVOLVE CERAMIC RADIAL HEAD IMPLANT— 510(k) K030384

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K030384 for EVOLVE CERAMIC RADIAL HEAD IMPLANT, Substantially Equivalent on 2003-08-12. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 2003-02-05
Decision date: 2003-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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.