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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K191854
Device Name Premia Spine XL Instruments
Applicant
Premia Spine, Ltd.
7 Giborey Israel St.
Ramat Poleg,  IL 42504
Applicant Contact Ron Sacher
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Hiladelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/10/2019
Decision Date 10/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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