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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
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