FDA 510(k) Application Details - K080184

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K080184
Device Name	Plate, Fixation, Bone
Applicant	I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH 3150 E. 200TH ST. PRIOR LAKE, MN 55372 US Other 510(k) Applications for this Company
Contact	AL LIPPINOCOTT Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2008
Decision Date	03/26/2008
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