Adaptix Interbody System with Titan nanoLOCK Surface Technology
K-Number: K250669 · 2025-04-22
ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2025-04-22
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 USA, Inc.. It received FDA 510(k) clearance on 2025-04-22 under approval number K250669. 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 2025-04-22. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K250669.
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 2025-04-22, under approval number K250669.
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 USA, Inc..
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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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.