FDA 510(k) Application Details - K965073

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K965073
Device Name	Screw, Fixation, Bone
Applicant	SMITH & NEPHEW, INC. 2777 LOKER AVE., WEST SUITE 100 CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	DAN W MILLER 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	12/19/1996
Decision Date	02/27/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review