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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K011137
Device Name RESORBABLE HAMMERTOE PIN
Applicant
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact SARA A BAILEY
Correspondent
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact SARA A BAILEY
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Codes
HTY   HWC  
Date Received04/13/2001
Decision Date 06/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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