OXINIUM DH Fermoral Heads— 510(k) K161233

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K161233 for OXINIUM DH Fermoral Heads, Substantially Equivalent on 2016-12-14. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code MBL
Advisory panel: Orthopedic
Date received: 2016-05-02
Decision date: 2016-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cordova, TN, US

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Adverse events under product code MBL

product code MBL

Injury: 439
Total: 439

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.