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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 K023022
Device Name NUGEN FX SCREW
Original Applicant
BIONX IMPLANTS, INC.
1777 sentry pkwy. west,
gwynedd hall, suite 400
blue bell,  PA  19422
Original Contact gerard s carlozzi
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/11/2002
Decision Date 10/04/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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