SMITH & NEPHEW MODULAR FEMORAL HEAD— 510(k) K061243

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K061243 for SMITH & NEPHEW MODULAR FEMORAL HEAD, Substantially Equivalent on 2006-07-17. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 2006-05-03
Decision date: 2006-07-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Memphis, TN, US

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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.