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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 K252597
Device Name Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
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 Number882.4560
Classification Product Code
OLO  
Date Received08/15/2025
Decision Date 02/19/2026
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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