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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 K232413
Device Name Fusion Robotic Navigation System
Applicant
Alphatec Spine, Inc.
168 Centennial Pkwy., Unit 170
Louisville,  CO  80027
Applicant Contact Sarah Braun
Correspondent
Alphatec Spine, Inc.
168 Centennial Pkwy., Unit 170
Louisville,  CO  80027
Correspondent Contact Sarah Braun
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/10/2023
Decision Date 09/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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