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TSRH Spinal System

by Medtronic Sofamor Danek, Inc. 12 variants

510(k) K010720

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 NumberK010720 Date11 Apr 2001ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 23 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 system for the non-cervical posterior spine in skeletally mature patients. It is indicated for one or more of the following: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).

The device is manufactured by Medtronic Sofamor Danek, Inc. and received FDA 510(k) clearance with K number K010720. It is authorized for use as a pedicle screw fixation system in the non-cervical posterior spine for skeletally mature patients with specific spinal conditions.

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Questions

AI-generated answers, 23 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 a pedicle screw fixation system designed for the non-cervical posterior spine in skeletally mature patients. It is indicated for treating degenerative disc disease, which is defined as back pain of discogenic origin with degeneration confirmed by patient history and radiographic studies.

  • How is the TSRH Spinal System supplied?

    The device is manufactured by Medtronic Sofamor Danek, Inc. and is supplied as a complete pedicle screw fixation system. The specific components and configurations available would depend on the surgical requirements and the particular model selected for the procedure.

  • What regulatory approvals does the TSRH Spinal System have?

    The TSRH Spinal System received FDA 510(k) clearance with K number K010720 on April 11, 2001. It was determined to be substantially equivalent to predicate devices and is authorized for use as a pedicle screw fixation system in the non-cervical posterior spine for skeletally mature patients with specific spinal conditions.

  • Is the TSRH Spinal system reusable or single-use?

    The device data does not specify whether the TSRH Spinal System is designed for single-use or multiple uses. This information would typically be found in the device's instructions for use, which would provide detailed guidance on sterilization, reprocessing, and reuse protocols if applicable.