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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K122378
Device Name NEXTGEN ALTIUS OCT SYSTEM
Original Applicant
BIOMET SPINE (AKA EBI, LLC)
100 interpace parkway
parsippany,  NJ  07054
Original Contact vivian kelly
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received08/06/2012
Decision Date 09/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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