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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 K183560
Device Name Luna 3D GEN2 Interbody Fusion System
Applicant
Benvenue Medical, Inc.
4590 Patrick Henry Dr.
Santa Clara,  CA  95054
Applicant Contact Laurent Schaller
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/20/2018
Decision Date 05/23/2019
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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