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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Intraoperative Spinal Rod Bending System
510(k) Number K253216
Device Name IntraOp Alignment System; CONTOUR3D Bending System
Applicant
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad,  CA  92008
Applicant Contact Unnati Bhuptani
Correspondent
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad,  CA  92008
Correspondent Contact Unnati Bhuptani
Regulation Number888.3070
Classification Product Code
SIN  
Subsequent Product Codes
JAA   LLZ   OWB  
Date Received09/29/2025
Decision Date 06/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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