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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 K201029
Device Name Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
Applicant
Spinal Elements, Inc.
3115 Melrose Dr. Suite 200
Carlsbad,  CA  92010
Applicant Contact Julie Lamothe
Correspondent
Spinal Elements, Inc.
3115 Melrose Dr. Suite 200
Carlsbad,  CA  92010
Correspondent Contact Julie Lamothe
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/20/2020
Decision Date 06/17/2020
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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