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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 K071377
Device Name POLARIS BE RODS
Applicant
BIOMET SPINE
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Applicant Contact DEBRA BING
Correspondent
BIOMET SPINE
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Correspondent Contact DEBRA BING
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI   NKB  
Date Received05/17/2007
Decision Date 08/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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