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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 K071498
Device Name SUBTALAR IMPLANT
Applicant
BIOMET SPORTS MEDICINE, INC.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact ELIZABETH WRAY
Correspondent
BIOMET SPORTS MEDICINE, INC.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact ELIZABETH WRAY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/31/2007
Decision Date 07/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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