SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM— 510(k) K121627

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K121627 for SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM, Substantially Equivalent on 2012-10-15. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 2012-06-04
Decision date: 2012-10-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Cordova, TN, US

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Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.