FDA 510(k)

Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments

K-Number: K221180 · 2022-05-25

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2022-05-25

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K221180. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments?

Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K221180.

When did Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments receive FDA 510(k) clearance?

Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments received FDA 510(k) clearance on 2022-05-25, under 510(k) number K221180.

Who is the listed applicant for Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments?

The FDA product code for Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments is OLO.

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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.