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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 K232719
Device Name ProMIS Extension Rod System
Applicant
Premia Spine Ltd.
7 Giborey Israel Street
Ramat Poleg, Netanya,  IL 4250407
Applicant Contact Dorit Winitz
Correspondent
Hogan Lovells US LLP
1735 Market St., 23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/05/2023
Decision Date 11/21/2023
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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