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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 K003077
Device Name SMARTSCREW MODEL 222006...227510
Original Applicant
BIONX IMPLANTS, LTD.
1777 sentry parkway west
bluebell,  PA  19422
Original Contact gerard s carlozzi
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received10/03/2000
Decision Date 04/26/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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