FDA 510(k) Application Details - K120903

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K120903
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	BRITTANY CUNNINGHAM 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	03/26/2012
Decision Date	07/13/2012
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