XYPAN Expandable Lumbar Cage System

Intervertebral Fusion Device With Bone Graft, Lumbar

Aegis Spine, Inc.

The following data is part of a premarket notification filed by Aegis Spine, Inc. with the FDA for Xypan Expandable Lumbar Cage System.

Pre-market Notification Details

Device IDK203531
510k NumberK203531
Device Name:XYPAN Expandable Lumbar Cage System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Aegis Spine, Inc. 9781 S. Meridian Blvd, Ste 300 Englewood,  CO  80112
ContactWoo Joong Kwon
CorrespondentMeredith Lee May
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-02
Decision Date2021-01-29

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