FDA 510(k) Application Details - K132731

Device Classification Name	Component, Traction, Invasive   More FDA Info for this Device
510(K) Number	K132731
Device Name	Component, Traction, Invasive
Applicant	VIRAK ORTHOPEDIC RESEARCH, LLC 3416 ROXEE RUN COVE BARTLETT, TN 38133 US Other 510(k) Applications for this Company
Contact	KIMBERLY STROHKIRCH Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2013
Decision Date	01/10/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review