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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 K182598
Device Name VersaLink™ Fixation System
Applicant
Premia Spine, Ltd.
8 Hampton Ct.
Westfield,  NJ  07090
Applicant Contact Ron Sacher
Correspondent
Hogan Lovells
555 Thirteenth St., Northwest
Washington,  DC  20004
Correspondent Contact Janice Hogan
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/20/2018
Decision Date 11/13/2018
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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