FDA 510(k)

CLYDESDALES SPINAL SYSTEM

K-Number: K112405 · 2011-11-21

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2011-11-21

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CLYDESDALES 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 2011-11-21 under 510(k) number K112405. 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 CLYDESDALES SPINAL SYSTEM?

CLYDESDALES SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-21. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K112405.

When did CLYDESDALES SPINAL SYSTEM receive FDA 510(k) clearance?

CLYDESDALES SPINAL SYSTEM received FDA 510(k) clearance on 2011-11-21, under 510(k) number K112405.

Who is the listed applicant for CLYDESDALES 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 CLYDESDALES SPINAL SYSTEM?

The FDA product code for CLYDESDALES 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.