FDA 510(k) Application Details - K163028

Device Classification Name	Component, Traction, Invasive   More FDA Info for this Device
510(K) Number	K163028
Device Name	Component, Traction, Invasive
Applicant	SURGICAL INSTRUMENT SERVICE AND SAVINGS INC 2747 SW 6TH ST. REDMOND, OR 97756 US Other 510(k) Applications for this Company
Contact	BRANDI J. PANTELEON 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	10/31/2016
Decision Date	12/28/2016
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