FDA 510(k) Application Details - K140649

Device Classification Name	System, External Fixator (With Metallic Invasive Components)   More FDA Info for this Device
510(K) Number	K140649
Device Name	System, External Fixator (With Metallic Invasive Components)
Applicant	3D MEDICAL CONCEPTS, LLC 1061 MORGAN PARK RD. Pelham, AL 35242 US Other 510(k) Applications for this Company
Contact	BEVERLY LAIRD Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	NDK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2014
Decision Date	12/29/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review