LxHA PEEK Lateral IBF System

Intervertebral Fusion Device With Bone Graft, Lumbar

Innovasis, Inc.

The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Lxha Peek Lateral Ibf System.

Pre-market Notification Details

Device IDK190684
510k NumberK190684
Device Name:LxHA PEEK Lateral IBF System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Innovasis, Inc. 614 East 3900 South Salt Lake City,  UT  84107
ContactMarshall Mccarty
CorrespondentMarshall Mccarty
Innovasis, Inc. 614 East 3900 South Salt Lake City,  UT  84107
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-18
Decision Date2019-06-17

NIH GUDID Devices

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