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TSRH Spinal System

by Medtronic Sofamor Danek, Inc.

510(k) K103049

Active United States. Also listed in GUDID (US).

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), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00613994790088 UDI-DI Date28 Jul 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK103049 Date23 Dec 2010ClearedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103049 decided 23 Dec 2010 Active
  • FDA GUDID UDI-DI 00613994790088 listed 28 Jul 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103049
  2. Listed FDA GUDID 00613994790088

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic name
Bone-screw internal spinal fixation system rod
Model / reference
1556001040
FDA applicant
Medtronic Sofamor Danek
Primary DI / UDI-DI
00613994790088
510(k) Number
FDA product code
NKB, MNH, MNI, KWQ, KWP
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class II
Regulation
21 CFR Part 888.3070 510(k)GUDID
888.3060 GUDID
888.3050 GUDID
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 40.0 Millimeter

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 under orthopedic instrumentation. It is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the thoracic, lumbar, and sacral regions.

The system includes rods, hooks, screws, cross connectors, staples, plates, and connecting components, enabling rigid locking in various configurations. Supplied as a reusable medical device, it is intended for use in skeletally mature patients and has received FDA 510(k) clearance under Special Review with a Substantially Equivalent determination (K103049).

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)