Ax 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 Ax Stand-alone Alif System.

Pre-market Notification Details

• Device ID: K162236
• 510k Number: K162236
• Device Name: Ax 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: 2016-08-09
• Decision Date: 2017-04-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M711LS3090	K162236	000
M711AX1236141	K162236	000
M711AX1240081	K162236	000
M711AX1240141	K162236	000
M711AX1430081	K162236	000
M711AX1430141	K162236	000
M711AX1430201	K162236	000
M711AX1436081	K162236	000
M711AX1436141	K162236	000
M711AX1436201	K162236	000
M711AX1440081	K162236	000
M711AX1440141	K162236	000
M711AX1630081	K162236	000
M711AX1630141	K162236	000
M711AX1630201	K162236	000
M711AX1236081	K162236	000
M711AX1230201	K162236	000
M711LS3120	K162236	000
M711LS3130	K162236	000
M711LS3210	K162236	000
M711LS3560	K162236	000
M711LS4480	K162236	000
M711AX010	K162236	000
M711AX020	K162236	000
M711AX1030081	K162236	000
M711AX1030141	K162236	000
M711AX1036081	K162236	000
M711AX1036141	K162236	000
M711AX1040081	K162236	000
M711AX1230081	K162236	000
M711AX1230141	K162236	000
M711AX1630301	K162236	000
M711AX1636081	K162236	000
M711AX2030081	K162236	000
M711AX2030141	K162236	000
M711AX2030201	K162236	000
M711AX2030301	K162236	000
M711AX2036081	K162236	000
M711AX2036141	K162236	000
M711AX2036201	K162236	000
M711AX2036301	K162236	000
M711AX2040081	K162236	000
M711AX2040141	K162236	000
M711AX2040201	K162236	000
M711AX2040301	K162236	000
M711AX55200	K162236	000
M711AX55250	K162236	000
M711AX1840201	K162236	000
M711AX1840141	K162236	000
M711AX1636141	K162236	000
M711AX1636201	K162236	000
M711AX1640081	K162236	000
M711AX1640141	K162236	000
M711AX1640201	K162236	000
M711AX1830081	K162236	000
M711AX1830141	K162236	000
M711AX1830201	K162236	000
M711AX1830301	K162236	000
M711AX1836081	K162236	000
M711AX1836141	K162236	000
M711AX1836201	K162236	000
M711AX1836301	K162236	000
M711AX1840081	K162236	000
M711AX55300	K162236	000