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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 K242364
Device Name IdentiTi™ II Interbody System
Applicant
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad,  CA  92008
Applicant Contact Sandy Gill
Correspondent
Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad,  CA  92008
Correspondent Contact Sandy Gill
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
OVD   PHM  
Date Received08/09/2024
Decision Date 10/04/2024
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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