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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
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city,  CA  90230 -7600
Original Contact crystal dizol
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/23/2007
Decision Date 09/12/2007
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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