EndoLIF Delta-Cage And DoubleWedge-Cage

Intervertebral Fusion Device With Bone Graft, Lumbar

Joimax GmbH

The following data is part of a premarket notification filed by Joimax Gmbh with the FDA for Endolif Delta-cage And Doublewedge-cage.

Pre-market Notification Details

Device IDK203014
510k NumberK203014
Device Name:EndoLIF Delta-Cage And DoubleWedge-Cage
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant joimax GmbH Amalienbadstrasse 41 Raumfabrik 61,  DE 76227
ContactGary Mocnik
CorrespondentGary Mocnik
Gary Mocnik And Associates 49 Coastal Oak Aliso Viejo,  CA  92656
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-01
Decision Date2021-09-01

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.