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TSRH Spinal System

by Medtronic Sofamor Danek, Inc. 12 variants

510(k) K093058

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 NumberK093058 Date26 Oct 2009ClearedStatusActive

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  • Withdrawn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
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 pedicle screw fixation device for the non-cervical posterior spine, classified as a spinal internal fixation system. It is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the thoracic, lumbar, and sacral regions.

This system includes rods, hooks, screws, cross connectors, staples, plates, and connecting components, which can be configured rigidly for individual patient needs. Supplied as a reusable surgical implant, it is regulated under FDA 510(k) clearance (K093058) and intended for skeletally mature patients. Components may also integrate with other Medtronic spinal systems.

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