UNIVERSAL TOTAL WRIST SYSTEM— 510(k) K030037

Substantially Equivalent

Kinetikos Medical, Inc.

FDA 510(k) clearance K030037 for UNIVERSAL TOTAL WRIST SYSTEM, Substantially Equivalent on 2003-02-05. Applicant: Kinetikos Medical, Inc..

Clearance details

Applicant: Kinetikos Medical, Inc.
Product code: Code JWJ
Advisory panel: Orthopedic
Date received: 2003-01-06
Decision date: 2003-02-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

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Adverse events under product code JWJ

product code JWJ

Injury: 181
Total: 181

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.