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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 K190881
Device Name Spinal Elements Navigated Instruments
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 Number882.4560
Classification Product Code
OLO  
Date Received04/04/2019
Decision Date 12/19/2019
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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