DIGIFIX EXTERNAL FIXATION SYSTEM— 510(k) K132731

Name: FDA 510(k) clearance K132731
Creator: U.S. Food and Drug Administration
Published: 2014-01-10

Substantially Equivalent

Virak Orthopedic Research, LLC

FDA 510(k) clearance K132731 for DIGIFIX EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 2014-01-10. Applicant: Virak Orthopedic Research, LLC. Device class: 2.

Clearance details

Applicant: Virak Orthopedic Research, LLC
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2013-09-03
Decision date: 2014-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

Download summary PDF View on FDA.gov ↗

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