FDA 510(k) Application Details - K160946

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K160946
Device Name	Screw, Fixation, Bone
Applicant	SMV SCIENTIFIC 111 SANDRA MURAIDA WAY UNIT 18A AUSTIN, TX 78703 US Other 510(k) Applications for this Company
Contact	Nephi Zufelt Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2016
Decision Date	12/05/2016
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