AXTi Titanium Stand-Alone ALIF System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Innovasis, Inc.

The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Axti Titanium Stand-alone Alif System.

Pre-market Notification Details

• Device ID: K182139
• 510k Number: K182139
• Device Name: AXTi Titanium Stand-Alone ALIF System
• Classification: Intervertebral Fusion Device With Integrated Fixation, 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: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-08-07
• Decision Date: 2019-06-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M711LS3880	K182139	000
M711AXTI1236141	K182139	000
M711AXTI1240081	K182139	000
M711AXTI1240141	K182139	000
M711AXTI1430081	K182139	000
M711AXTI1430141	K182139	000
M711AXTI1430201	K182139	000
M711AXTI1436081	K182139	000
M711AXTI1436141	K182139	000
M711AXTI1440081	K182139	000
M711AXTI1440141	K182139	000
M711AXTI1630081	K182139	000
M711AXTI1630141	K182139	000
M711AXTI1236081	K182139	000
M711AXTI1230201	K182139	000
M711AXTI1230141	K182139	000
M711LS3940	K182139	000
M711BTA1450	K182139	000
M711AXTI1436200	K182139	000
M711AXTI55250	K182139	000
M711AXTI55300	K182139	000
M711AXTI65250	K182139	000
M711AXTI65300	K182139	000
M711AXTI1030081	K182139	000
M711AXTI1030141	K182139	000
M711AXTI1036081	K182139	000
M711AXTI1040081	K182139	000
M711AXTI1230081	K182139	000
M711AXTI1630201	K182139	000
M711AXTI1630301	K182139	000
M711AXTI1840201	K182139	000
M711AXTI2030081	K182139	000
M711AXTI2030141	K182139	000
M711AXTI2030201	K182139	000
M711AXTI2030301	K182139	000
M711AXTI2036081	K182139	000
M711AXTI2036141	K182139	000
M711AXTI2036201	K182139	000
M711AXTI2036301	K182139	000
M711AXTI2040081	K182139	000
M711AXTI2040141	K182139	000
M711AXTI2040201	K182139	000
M711AXTI1840141	K182139	000
M711AXTI1840081	K182139	000
M711AXTI1836201	K182139	000
M711AXTI1636081	K182139	000
M711AXTI1636141	K182139	000
M711AXTI1636201	K182139	000
M711AXTI1640081	K182139	000
M711AXTI1640141	K182139	000
M711AXTI1640201	K182139	000
M711AXTI1830081	K182139	000
M711AXTI1830141	K182139	000
M711AXTI1830201	K182139	000
M711AXTI1830301	K182139	000
M711AXTI1836081	K182139	000
M711AXTI1836141	K182139	000
M711AXTI2040301	K182139	000