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 ID: K201614
• 510k Number: K201614
• Device Name: TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107
• Contact: Marshall Mccarty
• Correspondent: Marshall Mccarty; Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-06-15
• Decision Date: 2020-07-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M711TXT100728051	K201614	000
M711TXT101228121	K201614	000
M711TXT101328051	K201614	000
M711TXT101328101	K201614	000
M711TXT101328121	K201614	000
M711TXT101428051	K201614	000
M711TXT101428101	K201614	000
M711TXT101428121	K201614	000
M711TXT101528051	K201614	000
M711TXT101528101	K201614	000
M711TXT101528121	K201614	000
M711TXT101628051	K201614	000
M711TXT101228101	K201614	000
M711TXT101228051	K201614	000
M711TXT100828051	K201614	000
M711TXT100828101	K201614	000
M711TXT100928051	K201614	000
M711TXT100928101	K201614	000
M711TXT100928121	K201614	000
M711TXT101028051	K201614	000
M711TXT101028101	K201614	000
M711TXT101028121	K201614	000
M711TXT101128051	K201614	000
M711TXT101128101	K201614	000
M711TXT101128121	K201614	000
M711TXT101628101	K201614	000
M711TXT101628121	K201614	000
M711TXT121333051	K201614	000
M711TXT121333101	K201614	000
M711TXT121333121	K201614	000
M711TXT121433051	K201614	000
M711TXT121433101	K201614	000
M711TXT121433121	K201614	000
M711TXT121533051	K201614	000
M711TXT121533101	K201614	000
M711TXT121533121	K201614	000
M711TXT121633051	K201614	000
M711TXT121633101	K201614	000
M711TXT121233121	K201614	000
M711TXT121233101	K201614	000
M711TXT120833051	K201614	000
M711TXT120933051	K201614	000
M711TXT120933101	K201614	000
M711TXT120933121	K201614	000
M711TXT121033051	K201614	000
M711TXT121033101	K201614	000
M711TXT121033121	K201614	000
M711TXT121133051	K201614	000
M711TXT121133101	K201614	000
M711TXT121133121	K201614	000
M711TXT121233051	K201614	000
M711TXT121633121	K201614	000