Luna XD Ti Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Lumbar

Benvenue Medical, Inc.

The following data is part of a premarket notification filed by Benvenue Medical, Inc. with the FDA for Luna Xd Ti Interbody Fusion System.

Pre-market Notification Details

Device IDK193172
510k NumberK193172
Device Name:Luna XD Ti Interbody Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Benvenue Medical, Inc. 4590 Patrick Henry Dr. Santa Clara,  CA  95054
ContactLaurent Schaller
CorrespondentJustin Eggleton
MCRA, LLC 1050 K Street NW, Suite 1000 Washington,  DC  20001
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-15
Decision Date2020-07-02

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