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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 K150380
Device Name ProMIS Fixation System
Applicant
Premia Spine, Ltd.
7 Giborey Israel St.
Ramat Poleg,  IL 42504
Applicant Contact Ron Sacher
Correspondent
Premia Spine, Ltd.
7 Giborey Israel St.
Ramat Poleg,  IL 42504
Correspondent Contact Ron Sacher
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received02/13/2015
Decision Date 07/17/2015
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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