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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K063393
Device Name SMALL STATURE SPACERS
Applicant
BIOMET SPINE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact SUSAN ALEXANDER
Correspondent
BIOMET SPINE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact SUSAN ALEXANDER
Regulation Number888.3060
Classification Product Code
MQP  
Date Received11/09/2006
Decision Date 06/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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