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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 K151374
Device Name NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System
Applicant
NuVasive, Incorporated
7475 Lusk Boulevard
San Diego,  CA  92121
Applicant Contact Olga Lewis
Correspondent
NuVasive, Incorporated
7475 Lusk Boulevard
San Diego,  CA  92121
Correspondent Contact Olga Lewis
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/22/2015
Decision Date 08/06/2015
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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