ZIRCONIUM ALLOY UNI-POLAR HEAD— 510(k) K934353

Name: FDA 510(k) clearance K934353
Creator: U.S. Food and Drug Administration
Published: 1994-04-25

Substantially Equivalent

Smith & Nephew Richards, Inc.

FDA 510(k) clearance K934353 for ZIRCONIUM ALLOY UNI-POLAR HEAD, Substantially Equivalent on 1994-04-25. Applicant: Smith & Nephew Richards, Inc.. Device class: 2.

Clearance details

Applicant: Smith & Nephew Richards, Inc.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1993-09-08
Decision date: 1994-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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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.