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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
Applicant
BIONX IMPLANTS, LTD.
1777 SENTRY PARKWAY WEST
BLUEBELL,  PA  19422
Applicant Contact GERARD S CARLOZZI
Correspondent
BIONX IMPLANTS, LTD.
1777 SENTRY PARKWAY WEST
BLUEBELL,  PA  19422
Correspondent 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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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