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Tsrh Spinal System

by Medtronic Sofamor Danek, Inc.

510(k) K090740

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK090740 Date14 Aug 2009ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Modification to: Tsrh Spinal System
510(k) Number
FDA product code
NKB
FDA applicant
Medtronic Sofamor Danek
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tsrh Spinal System is an orthopedic device. It is a spinal system used in orthopedic applications.

The device is supplied as a modification to the existing Tsrh Spinal System and has been cleared through the Special 510(k) pathway with FDA 510(k) authorizations, including K090740. It is classified as a Class 2 device with product code NKB.

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