FDA 510(k) Application Details - K111001

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K111001
Device Name	Screw, Fixation, Bone
Applicant	INTELLIGENT ORTHOPAEDICS LTD STAFFORDSHIRE UNIVERSITY BUSINESS VILLAGE, LEEK ROAD STOKE ON TRENT, STAFFORDSHIRE ST4 2AR GB Other 510(k) Applications for this Company
Contact	PETER J OGRODNIK 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	04/11/2011
Decision Date	05/17/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review