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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K111001
Device Name STERILE STORM (R) OPERATING KIT
Applicant
INTELLIGENT ORTHOPAEDICS LTD
STAFFORDSHIRE UNIVERSITY
BUSINESS VILLAGE, LEEK ROAD
STOKE ON TRENT, STAFFORDSHIRE,  GB ST4 2AR
Applicant Contact PETER J OGRODNIK
Correspondent
INTELLIGENT ORTHOPAEDICS LTD
STAFFORDSHIRE UNIVERSITY
BUSINESS VILLAGE, LEEK ROAD
STOKE ON TRENT, STAFFORDSHIRE,  GB ST4 2AR
Correspondent Contact PETER J OGRODNIK
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTY  
Date Received04/11/2011
Decision Date 05/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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