Momentum Posterior Spinal Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191932 FDA 510(k)
- FDA Product Code
- NKB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3070 FDA 510(k)
- Regulation Number
- 888.3070 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Momentum Posterior Spinal Fixation System is a rod-screw system for posterior spinal fixation, featuring dual lead and cortical-to-cancellous thread design with aggressive distal tip. It includes polyaxial screws with friction head, cannulated and non-cannulated screw options, and iliac screws with open and closed tulip heads. The system is designed for T1 - sacroiliac fixation.
The Momentum Posterior Spinal Fixation System is supplied with various screw diameters, including 5.5mm - 7.5mm, and is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system has FDA 510K authorization and is manufactured by Ulrich Medical USA.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Momentum® - Posterior Spinal Fixation System - ulrich medical USA, Momentum MIS® - Posterior Spinal Fixation System, PDF Momentum M - thespinemarketgroup.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191932 | Class II | Active |
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Manufacturer
- Manufacturer
- Ulrich Medical USA
Sources (1)
- FDA 510(k) K191932 24 fields · synced Sep 27, 2026