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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 K024086
Device Name PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
Applicant
BIOMET ORTHOPEDICS, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact KACY ARNOLD
Correspondent
BIOMET ORTHOPEDICS, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact KACY ARNOLD
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/11/2002
Decision Date 01/09/2003
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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