FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT— 510(k) K112481

Name: FDA 510(k) clearance K112481
Creator: U.S. Food and Drug Administration
Published: 2012-04-09

Substantially Equivalent

Ascension Orthopedic

FDA 510(k) clearance K112481 for FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT, Substantially Equivalent on 2012-04-09. Applicant: Ascension Orthopedic. Device class: 2.

Clearance details

Applicant: Ascension Orthopedic
Product code: Code KXE
Device class: Class 2
Regulation: 21 CFR 888.3810
Advisory panel: Orthopedic
Date received: 2011-08-29
Decision date: 2012-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.