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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K243461
Device Name Calibrate Interbody Systems
Applicant
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad,  CA  92008
Applicant Contact Andrew Zhang
Correspondent
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad,  CA  92008
Correspondent Contact Andrew Zhang
Subsequent Product Code
MAX  
Date Received11/08/2024
Decision Date 03/04/2025
Decision Substantially Equivalent (SESE)
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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