FDA 510(k) Application Details - K063460

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K063460
Device Name	Plate, Fixation, Bone
Applicant	ACUMED LLC 5885 NW CORNELIUS PASS RD. HILLSBORO, OR 97124-9432 US Other 510(k) Applications for this Company
Contact	ED BOEHMER 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	11/15/2006
Decision Date	12/07/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review