FDA 510(k) Application Details - K153338

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K153338
Device Name	Screw, Fixation, Bone
Applicant	Trilliant Surgical, LTD 6721 Portwest Dr Ste 160 Houston, TX 77024 US Other 510(k) Applications for this Company
Contact	Jon Olson 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	11/19/2015
Decision Date	01/14/2016
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