VECTRIX EXTERNAL FIXATOR— 510(k) K140649

Name: FDA 510(k) clearance K140649
Creator: U.S. Food and Drug Administration
Published: 2014-12-29

Substantially Equivalent

3D Medical Concepts, LLC

FDA 510(k) clearance K140649 for VECTRIX EXTERNAL FIXATOR, Substantially Equivalent on 2014-12-29. Applicant: 3D Medical Concepts, LLC. Device class: 2.

Clearance details

Applicant: 3D Medical Concepts, LLC
Product code: Code NDK
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2014-03-13
Decision date: 2014-12-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Pelham, AL, US

Download summary PDF View on FDA.gov ↗

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