FDA 510(k)

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF

K-Number: K212389 · 2021-10-29

Decision Date2021-10-29

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF is a medical device manufactured by Intelivation, LLC. It received FDA 510(k) clearance on 2021-10-29 under approval number K212389. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF?

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF is a medical device that received FDA 510(k) clearance on 2021-10-29. It is manufactured by Intelivation, LLC. The 510(k) number is K212389.

When was Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF approved by the FDA?

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF received FDA 510(k) clearance on 2021-10-29, under approval number K212389.

What company makes Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF?

Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF is manufactured by Intelivation, LLC.

What is the FDA product code for Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF?

The FDA product code for Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF is MAX.

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Official Source

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