Europa Pedicle Screw System
FDA 510(k)Class II (US FDA 510(k))
by Mirus Llc
Identifiers
- 510(k) Number
- K182970 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 Europa Pedicle Screw System is a spinal implant system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. It is a type of orthopedic device.
The system is supplied with Dual Pitch 4.5mm MoRe Rods and is used in spinal surgery. The device has received FDA 510K authorization. The system is designed for use in skeletally mature patients and is intended to assist in the treatment of spinal instabilities or deformities.
Frequently asked questions
What is the EUROPA Pedicle Screw System used for?
The EUROPA Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Who is the EUROPA Pedicle Screw System designed for?
The system is designed for use in skeletally mature patients, meaning it is intended for individuals whose skeletal growth has completed, typically adults, to treat spinal instabilities or deformities.
What components are included with the EUROPA Pedicle Screw System?
The system is supplied with Dual Pitch 4.5mm MoRe Rods, which are used during spinal surgery to provide structural support and stabilization when implanted as part of the pedicle screw construct.
How was the EUROPA Pedicle Screw System authorized for market release?
The device received FDA 510K authorization, specifically through a traditional clearance process, and was found substantially equivalent to a predicate device, as indicated by the decision code SESE and clearance type Traditional.
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: EUROPA® Pedicle Screw System - MiRus, EUROPA™ - SPINEMarketGroup, EUROPA® Navigated Instruments System - MiRus
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182970 | Class II | Active |
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Manufacturer
- Manufacturer
- Mirus Llc
- FDA Applicant
- MiRus, LLC
Sources (1)
- FDA 510(k) K182970 24 fields · synced Sep 24, 2026