Navagio Lumbar Cage

Intervertebral Fusion Device With Bone Graft, Lumbar

Kalitec Medical, LLC

The following data is part of a premarket notification filed by Kalitec Medical, Llc with the FDA for Navagio Lumbar Cage.

Pre-market Notification Details

Device IDK220902
510k NumberK220902
Device Name:Navagio Lumbar Cage
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Kalitec Medical, LLC 618 E. South Street, Suite 500 Orlando,  FL  32801
ContactScott Winn
CorrespondentJ. D. Webb
The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven,  UT  84401
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-28
Decision Date2022-05-27

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