FDA 510(k) Application Details - K111971

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K111971
Device Name	Screw, Fixation, Bone
Applicant	TARSUS MEDICAL INC. 465 FAIRCHILD DRIVE SUITE 230 MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	NICHOLAS MOURLAS 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	07/11/2011
Decision Date	01/23/2012
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