QUATRO M FEMORAL COMPONENT— 510(k) K033313

Substantially Equivalent

Whiteside Biomechanics, Inc.

FDA 510(k) clearance K033313 for QUATRO M FEMORAL COMPONENT, Substantially Equivalent on 2004-07-28. Applicant: Whiteside Biomechanics, Inc..

Clearance details

Applicant: Whiteside Biomechanics, Inc.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 2003-10-15
Decision date: 2004-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Creve Coeur, MO, US

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.