TSRH Spinal System
by Medtronic Sofamor Danek, Inc. 12 variants
510(k) K031967
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031967 | Date17 Sep 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNI
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The TSRH Spinal System is a pedicle screw fixation device designed for non-cervical posterior spine stabilization. Classified under orthopedic instrumentation, it provides rigid immobilization and structural support to spinal segments as an adjunct to fusion procedures in the thoracic, lumbar, and sacral regions. The system includes rods, hooks, screws, cross connectors, staples, plates, and modular components that can be configured for customised spinal constructs. Its primary function is to enhance spinal stability during surgical interventions for degenerative conditions or deformities.
This system is intended for use in skeletally mature patients and is supplied as a reusable surgical instrument set, with implant components intended for single-use. Components are compatible with MRI environments, though specific safety parameters must be verified per facility protocols. The system is authorised under FDA 510(k) clearance (K031967) as substantially equivalent to predicate devices, adhering to traditional review pathways. Storage and handling follow standard orthopedic implant protocols to maintain sterility and functionality.
Other devices from Medtronic Sofamor Danek, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the TSRH Spinal System used for?
The TSRH Spinal System is designed for non-cervical posterior spine stabilization in skeletally mature patients. It provides rigid immobilization and structural support as an adjunct to fusion procedures for degenerative conditions or spinal deformities in the thoracic, lumbar, and sacral regions. The modular components allow for customizable spinal constructs tailored to specific surgical needs.
How is the TSRH Spinal System supplied, and what are its usage guidelines?
The TSRH Spinal System is supplied as a reusable surgical instrument set, with implant components intended for single-use only. This ensures sterility and safety for each surgical procedure. The system includes rods, hooks, screws, cross connectors, staples, and plates, all designed to work together for spinal stabilization.
Are the implant components of the TSRH Spinal System compatible with MRI environments?
Yes, the implant components of the TSRH Spinal System are compatible with MRI environments. However, each facility must verify specific safety parameters and protocols before use, as MRI settings can vary. This ensures patient safety during post-operative imaging.
What regulatory pathway does the TSRH Spinal System follow?
The TSRH Spinal System is authorized under FDA 510(k) clearance (K031967) and is classified as substantially equivalent to predicate devices. It follows the traditional review pathway, adhering to established orthopedic instrumentation standards. This clearance confirms its compliance with FDA requirements for spinal fixation devices.
How should the TSRH Spinal System be stored to maintain functionality?
The TSRH Spinal System should be stored following standard orthopedic implant protocols to preserve sterility and functionality. Reusable surgical instruments must be cleaned, sterilized, and stored in a controlled environment as per manufacturer guidelines. Single-use implant components should remain in their sterile packaging until immediately before use to prevent contamination.