FDA 510(k) Application Details - K012817

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K012817
Device Name	Screw, Fixation, Bone
Applicant	TRIAGE MEDICAL INC 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND 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	08/22/2001
Decision Date	11/20/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review