TxTiHA IBF System, AxTiHA Stand-Alone ALIF 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 Txtiha Ibf System, Axtiha Stand-alone Alif System.

Pre-market Notification Details

Device IDK201614
510k NumberK201614
Device Name:TxTiHA IBF System, AxTiHA Stand-Alone ALIF 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2020-07-15

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