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FDA 510(k)

Stand-Alone ALIF Titanium System

K-Number: K191834 · 2019-12-16

ApplicantLife Spine, Inc.
Decision Date2019-12-16
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stand-Alone ALIF Titanium System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2019-12-16 under approval number K191834. 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 Stand-Alone ALIF Titanium System?

Stand-Alone ALIF Titanium System is a medical device that received FDA 510(k) clearance on 2019-12-16. It is manufactured by Life Spine, Inc.. The 510(k) number is K191834.

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

Stand-Alone ALIF Titanium System received FDA 510(k) clearance on 2019-12-16, under approval number K191834.

What company makes Stand-Alone ALIF Titanium System?

Stand-Alone ALIF Titanium System is manufactured by Life Spine, Inc..

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

The FDA product code for Stand-Alone ALIF Titanium 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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