SOLITUDE UNIPOLAR HEAD— 510(k) K042973

Substantially Equivalent

Ortho Development Corp.

FDA 510(k) clearance K042973 for SOLITUDE UNIPOLAR HEAD, Substantially Equivalent on 2005-01-27. Applicant: Ortho Development Corp..

Clearance details

Applicant: Ortho Development Corp.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 2004-10-28
Decision date: 2005-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, 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.