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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 K214010
Device Name Anteralign Spinal System with Titan nanoLOCK Surface Technology
Applicant
Medtronic Sofamor Danek USA
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact Elizabeth Hamilton
Correspondent
Medtronic Sofamor Danek USA
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact Elizabeth Hamilton
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
OVD  
Date Received12/22/2021
Decision Date 04/12/2022
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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