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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K252842
Device Name SafeOp 3: Neural Informatix System
Applicant
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad,  CA  92008
Applicant Contact Garima Shrivastava
Correspondent
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad,  CA  92008
Correspondent Contact Garima Shrivastava
Regulation Number882.1870
Classification Product Code
GWF  
Date Received09/08/2025
Decision Date 01/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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