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FDA 510(k)

Symmetrix™ L Spinal System

K-Number: K261020 · 2026-07-14

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2026-07-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Symmetrix™ L Spinal System 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 2026-07-14 under 510(k) number K261020. 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 Symmetrix™ L Spinal System?

Symmetrix™ L Spinal System is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K261020.

When did Symmetrix™ L Spinal System receive FDA 510(k) clearance?

Symmetrix™ L Spinal System received FDA 510(k) clearance on 2026-07-14, under 510(k) number K261020.

Who is the listed applicant for Symmetrix™ L Spinal System?

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 Symmetrix™ L Spinal System?

The FDA product code for Symmetrix™ L Spinal System 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.

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