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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(k) Number K251575
Device Name IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System
Applicant
Alphatec Spine
1950 Camino Vida Roble
Carlsbad,  CA  92008
Applicant Contact Alanna Joshi
Correspondent
Alphatec Spine
1950 Camino Vida Roble
Carlsbad,  CA  92008
Correspondent Contact Alanna Joshi
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received05/22/2025
Decision Date 09/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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