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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 K071437
Device Name MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
Original Applicant
600 corporate pointe
culver city,  CA  90230 7600
Original Contact crystal dizol
Regulation Number888.3040
Classification Product Code
Date Received06/19/2007
Decision Date 09/12/2007
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