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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K200523
Device Name Biolign® Roto-Loc Cervical Plate System
Applicant
Elite Surgical Supplies (Pty), Ltd.
54 De Havilland Cresent, Persequor Technopark
Pretoria,  ZA 0020
Applicant Contact Thanos Spirakis
Correspondent
Jalex Medical
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Jordan Floyd
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/02/2020
Decision Date 04/30/2020
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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