DISTAL RADIO-ULNAR JOINT IMPLANT— 510(k) K053119

Name: FDA 510(k) clearance K053119
Creator: U.S. Food and Drug Administration
Published: 2005-12-07

Substantially Equivalent

Aptis Medical, LLC

FDA 510(k) clearance K053119 for DISTAL RADIO-ULNAR JOINT IMPLANT, Substantially Equivalent on 2005-12-07. Applicant: Aptis Medical, LLC. Device class: 2.

Clearance details

Applicant: Aptis Medical, LLC
Product code: Code KXE
Device class: Class 2
Regulation: 21 CFR 888.3810
Advisory panel: Orthopedic
Date received: 2005-11-07
Decision date: 2005-12-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

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