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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 K972919
Device Name BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW
Original Applicant
BIONX IMPLANTS, INC.
555 13th street, n.w.
washington,  DC  20004
Original Contact jonathan s kahan
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received08/07/1997
Decision Date 03/27/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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