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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 K153603
Device Name Alphatec Navigation Instruments
Applicant
Alphatec Spine, Inc.
5818 El Camino Real
Carlsnad,  CA  92008
Applicant Contact RENEE MURPHY
Correspondent
Alphatec Spine, Inc.
5818 El Camino Real
Carlsnad,  CA  92008
Correspondent Contact RENEE MURPHY
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/17/2015
Decision Date 04/29/2016
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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