FDA 510(k)

Adaptix Interbody System with Titan nanoLOCK Surface Technology

K-Number: K201267 · 2020-08-26

Decision Date2020-08-26

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Adaptix Interbody System with Titan nanoLOCK Surface Technology is a medical device manufactured by Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2020-08-26 under approval number K201267. 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 Adaptix Interbody System with Titan nanoLOCK Surface Technology?

Adaptix Interbody System with Titan nanoLOCK Surface Technology is a medical device that received FDA 510(k) clearance on 2020-08-26. It is manufactured by Medtronic Sofamor Danek. The 510(k) number is K201267.

When was Adaptix Interbody System with Titan nanoLOCK Surface Technology approved by the FDA?

Adaptix Interbody System with Titan nanoLOCK Surface Technology received FDA 510(k) clearance on 2020-08-26, under approval number K201267.

What company makes Adaptix Interbody System with Titan nanoLOCK Surface Technology?

Adaptix Interbody System with Titan nanoLOCK Surface Technology is manufactured by Medtronic Sofamor Danek.

What is the FDA product code for Adaptix Interbody System with Titan nanoLOCK Surface Technology?

The FDA product code for Adaptix Interbody System with Titan nanoLOCK Surface Technology is MAX.

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Related Devices (Code: 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.