ORTHOSPHERE CERAMIC SPHERICAL IMPLANT— 510(k) K030319

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K030319 for ORTHOSPHERE CERAMIC SPHERICAL IMPLANT, Substantially Equivalent on 2003-11-26. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2003-01-30
Decision date: 2003-11-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arlington, TN, US

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Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.