Anteralign Spinal System with Titan nanoLOCK Surface Technology
K-Number: K214010 · 2022-04-12
ApplicantMedtronic Sofamor Danek USA
Decision Date2022-04-12
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. It received FDA 510(k) clearance on 2022-04-12 under approval number K214010. 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 2022-04-12. It is manufactured by Medtronic Sofamor Danek USA. The 510(k) number is K214010.
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 2022-04-12, under approval number K214010.
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.
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.