FDA 510(k) Application Details - K122489

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K122489
Device Name	Screw, Fixation, Bone
Applicant	EMERGE MEDICAL 790 S. COLORADO BLVD SUITE 550-S DENVER, CO 80246 US Other 510(k) Applications for this Company
Contact	VICTORIA TRAFKA 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	08/15/2012
Decision Date	12/10/2012
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