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TSRH Spinal System

by Medtronic Sofamor Danek, Inc. 12 variants

510(k) K110676

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK110676 Date23 May 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 28 Sep 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 a device intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. It is designed for use as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients.

The system is manufactured by Medtronic Sofamor Danek, Inc. and is supplied in various sizes. It has received FDA 510(k) clearance with the K number K110676. The device is intended for use in treating conditions such as degenerative disc disease, as specified in the regulatory authorization.

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Questions

AI-generated answers, 28 Sep 2026

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

  • What is the TSRH Spinal System used for?

    The TSRH Spinal System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine in skeletally mature patients with conditions such as degenerative disc disease.

  • How is the TSRH Spinal System supplied?

    The system is manufactured by Medtronic Sofamor Danek, Inc. and is supplied in various sizes to accommodate different patient anatomies and surgical requirements.

  • What is the regulatory status of the TSRH Spinal System?

    The TSRH Spinal System has received FDA 510(k) clearance with K number K110676, classified as substantially equivalent to predicate devices for pedicle screw fixation of the non-cervical posterior spine.

  • Which spinal regions can the TSRH Spinal System be used on?

    The system is intended for use in the thoracic, lumbar, and/or sacral spine regions as a pedicle screw fixation system for the non-cervical posterior spine in skeletally mature patients.