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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 Bone Graft, Lumbar
510(k) Number K241375
Device Name IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer
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
MAX  
Subsequent Product Codes
ODP   OVD   OVE   PHM  
Date Received05/15/2024
Decision Date 02/03/2025
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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