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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 K140123
Device Name POLARIS SPINAL SYSTEM -TRANSLATION SCREW
Applicant
Ebi, LLC
399 Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact MIKE MEDINA
Correspondent
Ebi, LLC
399 Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact MIKE MEDINA
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received01/16/2014
Decision Date 04/24/2014
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
Recalls CDRH Recalls
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