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FDA 510(k)

AXTi Titanium Stand-Alone ALIF System

K-Number: K182139 · 2019-06-21

ApplicantInnovasis, Inc.
Decision Date2019-06-21
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AXTi Titanium Stand-Alone ALIF System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2019-06-21 under approval number K182139. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXTi Titanium Stand-Alone ALIF System?

AXTi Titanium Stand-Alone ALIF System is a medical device that received FDA 510(k) clearance on 2019-06-21. It is manufactured by Innovasis, Inc.. The 510(k) number is K182139.

When was AXTi Titanium Stand-Alone ALIF System approved by the FDA?

AXTi Titanium Stand-Alone ALIF System received FDA 510(k) clearance on 2019-06-21, under approval number K182139.

What company makes AXTi Titanium Stand-Alone ALIF System?

AXTi Titanium Stand-Alone ALIF System is manufactured by Innovasis, Inc..

What is the FDA product code for AXTi Titanium Stand-Alone ALIF System?

The FDA product code for AXTi Titanium Stand-Alone ALIF System is OVD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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