UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)— 510(k) K961051

Substantially Equivalent

Kinetikos Medical, Inc.

FDA 510(k) clearance K961051 for UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION), Substantially Equivalent on 1996-06-06. Applicant: Kinetikos Medical, Inc..

Clearance details

Applicant: Kinetikos Medical, Inc.
Product code: Code JWJ
Advisory panel: Orthopedic
Date received: 1996-03-11
Decision date: 1996-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, 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.