ULTIMA UNIPOLAR MODULAR HEAD— 510(k) K940190

Substantially Equivalent

Johnson & Johnson Orthopaedics, Inc.

FDA 510(k) clearance K940190 for ULTIMA UNIPOLAR MODULAR HEAD, Substantially Equivalent on 1994-09-29. Applicant: Johnson & Johnson Orthopaedics, Inc..

Clearance details

Applicant: Johnson & Johnson Orthopaedics, Inc.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1994-01-13
Decision date: 1994-09-29
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.