ULTIMA TPS CEMENTED STEM— 510(k) K965198

Substantially Equivalent

Johnson & Johnson International

FDA 510(k) clearance K965198 for ULTIMA TPS CEMENTED STEM, Substantially Equivalent on 1997-07-23. Applicant: Johnson & Johnson International.

Clearance details

Applicant: Johnson & Johnson International
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1996-12-26
Decision date: 1997-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, 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.