FDA 510(k) Application Details - K111994

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K111994
Device Name	Screw, Fixation, Bone
Applicant	SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 US Other 510(k) Applications for this Company
Contact	MAUREEN WHITSON 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	07/13/2011
Decision Date	10/11/2011
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