FDA 510(k) Application Details - K963118

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K963118
Device Name	Screw, Fixation, Bone
Applicant	ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 BEAVERTON, OR 97005 US Other 510(k) Applications for this Company
Contact	SHARI L JEFFERS 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	08/12/1996
Decision Date	10/10/1996
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review