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TSRH Spinal System

by Medtronic Sofamor Danek, Inc. 12 variants

510(k) K091797

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 · Traditional NumberK091797 Date30 Apr 2010ClearedStatusActive

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  • Withdrawn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, 21 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 spinal orthopedic device used for the stabilization and fixation of the vertebral column. It is designed to provide structural support in spinal procedures involving instrumentation of the spine.

The device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the healthcare facility. It is used in hospital or surgical center settings and is not MRI safe. The system includes various components such as rods, screws, hooks, and connectors, available in multiple sizes to accommodate patient anatomy and surgical needs. Authorization is based on FDA 510(k) clearance under product code NKB, with a determination of substantial equivalence.

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Questions

AI-generated answers, 21 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 used for the stabilization and fixation of the vertebral column, providing structural support in spinal procedures involving instrumentation of the spine.

  • How is the TSRH Spinal System supplied and is it reusable?

    The device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the healthcare facility, meaning it must be reprocessed before each surgical use.

  • What components are included in the TSRH Spinal System and are sizes variable?

    The system includes various components such as rods, screws, hooks, and connectors, available in multiple sizes to accommodate patient anatomy and surgical needs.

  • In what settings is the TSRH Spinal System used and is it MRI safe?

    The device is used in hospital or surgical center settings and is not MRI safe, so it should not be used in environments with strong magnetic fields.

  • What regulatory pathway was used for the TSRH Spinal System?

    Authorization is based on FDA 510(k) clearance under product code NKB, with a determination of substantial equivalence to a legally marketed predicate device.