Medussa-PL Cage

Intervertebral Fusion Device With Bone Graft, Lumbar

Medyssey USA, Inc.

The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Medussa-pl Cage.

Pre-market Notification Details

Device IDK200283
510k NumberK200283
Device Name:Medussa-PL Cage
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medyssey USA, Inc. 1550 E. Higgins Road, Suite 123 Elk Grove Village,  IL  60007
ContactShawn Kim
CorrespondentJustin Eggleton
MCRA, LLC 1050 K Street NW, Suite 1000 Washington,  DC  20001
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-04
Decision Date2020-06-18

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