RADIAL HEAD PROSTHESIS— 510(k) K992220

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K992220 for RADIAL HEAD PROSTHESIS, Substantially Equivalent on 2000-02-25. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 1999-07-01
Decision date: 2000-02-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Memphis, TN, US

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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.