FDA 510(k) Application Details - K973309

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K973309
Device Name	Screw, Fixation, Bone
Applicant	VILEX, INC. 811 RT. 51, INDUSTRIAL COMPLEX BLDG. 10 LARGE, PA 15025 US Other 510(k) Applications for this Company
Contact	ABRAHAM LAVI 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	09/03/1997
Decision Date	01/16/1998
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