FDA 510(k) Application Details - K163487

Device Classification Name	Pin, Fixation, Threaded   More FDA Info for this Device
510(K) Number	K163487
Device Name	Pin, Fixation, Threaded
Applicant	Vilex in Tennessee, Inc 111 Moffitt Street McMinnville, TN 37110 US Other 510(k) Applications for this Company
Contact	Sylvia Southard Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2016
Decision Date	02/13/2017
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