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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K160465
Device Name Spinal Elements' Spinous Process Plate 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, Ph.D., MBA
Regulation Number888.3050
Classification Product Code
PEK  
Date Received02/19/2016
Decision Date 07/28/2016
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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