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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 K193172
Device Name Luna XD Ti Interbody Fusion System
Applicant
Benvenue Medical, Inc.
4590 Patrick Henry Dr.
santa clara,  CA  95054
Applicant Contact laurent schaller
Correspondent
MCRA, LLC
1050 K Street NW, Suite 1000
washington,  DC  20001
Correspondent Contact justin eggleton
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/15/2019
Decision Date 07/02/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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