Anteralign Spinal System with Titan nanoLOCK Surface Technology
K-Number: K212524 · 2021-12-08
ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2021-12-08
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Anteralign Spinal System with Titan nanoLOCK Surface Technology is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2021-12-08 under approval number K212524. 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 Anteralign Spinal System with Titan nanoLOCK Surface Technology?
Anteralign Spinal System with Titan nanoLOCK Surface Technology is a medical device that received FDA 510(k) clearance on 2021-12-08. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K212524.
When was Anteralign Spinal System with Titan nanoLOCK Surface Technology approved by the FDA?
Anteralign Spinal System with Titan nanoLOCK Surface Technology received FDA 510(k) clearance on 2021-12-08, under approval number K212524.
What company makes Anteralign Spinal System with Titan nanoLOCK Surface Technology?
Anteralign Spinal System with Titan nanoLOCK Surface Technology is manufactured by Medtronic Sofamor Danek USA, Inc..
What is the FDA product code for Anteralign Spinal System with Titan nanoLOCK Surface Technology?
The FDA product code for Anteralign Spinal 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.