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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 K172967
Device Name Mercury® 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 Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received09/26/2017
Decision Date 04/10/2018
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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