FDA 510(k) Application Details - K961157

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K961157
Device Name	Screw, Fixation, Bone
Applicant	WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. CREVE COEUR, MO 63141 US Other 510(k) Applications for this Company
Contact	MICHAEL C WALL, R.N. 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	03/22/1996
Decision Date	05/17/1996
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