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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K221821
Device Name ATEC IOM Accessory Instruments
Applicant
Alphatec Spine, Inc.
1950 Camino Vido Roble
Carlsbad,  CA  92008
Applicant Contact Sandy Gill
Correspondent
Alphatec Spine, Inc.
1950 Camino Vido Roble
Carlsbad,  CA  92008
Correspondent Contact Sandy Gill
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Code
ETN  
Date Received06/23/2022
Decision Date 09/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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