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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K100409
Device Name POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
Applicant
BIOMET SPINE (AKA EBI, LLC)
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Applicant Contact VIVIAN KELLY MS, RAC
Correspondent
BIOMET SPINE (AKA EBI, LLC)
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Correspondent Contact VIVIAN KELLY MS, RAC
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received02/16/2010
Decision Date 06/23/2010
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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