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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K211987
Device Name ATEC Alignment App
Applicant
Alphatec Spine, Inc.
1950 Camina Vida Roble
Carlsbad,  CA  92008
Applicant Contact David Gramse
Correspondent
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad,  CA  92008
Correspondent Contact David Gramse
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/28/2021
Decision Date 10/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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