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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
Applicant
BIONX IMPLANTS, INC.
1777 SENTRY PKWY. WEST,
GWYNEDD HALL, SUITE 400
BLUE BELL,  PA  19422
Applicant Contact GERARD S CARLOZZI
Correspondent
BIONX IMPLANTS, INC.
1777 SENTRY PKWY. WEST,
GWYNEDD HALL, SUITE 400
BLUE BELL,  PA  19422
Correspondent Contact GERARD S CARLOZZI
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/11/2002
Decision Date 10/04/2002
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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