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FDA 510(k)

TSRH SPINAL SYSTEMS

K-Number: K111942 · 2011-08-30

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2011-08-30
Product CodeNKB
Advisory CommitteeOR
DecisionUnknown

Device Summary

TSRH SPINAL SYSTEMS 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 2011-08-30 under 510(k) number K111942. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TSRH SPINAL SYSTEMS?

TSRH SPINAL SYSTEMS is a medical device that received FDA 510(k) clearance on 2011-08-30. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K111942.

When did TSRH SPINAL SYSTEMS receive FDA 510(k) clearance?

TSRH SPINAL SYSTEMS received FDA 510(k) clearance on 2011-08-30, under 510(k) number K111942.

Who is the listed applicant for TSRH SPINAL SYSTEMS?

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 TSRH SPINAL SYSTEMS?

The FDA product code for TSRH SPINAL SYSTEMS is NKB.

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Related Devices (Code: NKB)

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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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