Aptis Medical Distal Radio Ulnar Joint Implant— 510(k) K142569

Name: FDA 510(k) clearance K142569
Creator: U.S. Food and Drug Administration
Published: 2015-04-03

Substantially Equivalent

Aptis Medical, LLC

FDA 510(k) clearance K142569 for Aptis Medical Distal Radio Ulnar Joint Implant, Substantially Equivalent on 2015-04-03. 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: 2014-09-12
Decision date: 2015-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glenview, KY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.