Europa Pedicle Screw System
FDA 510(k)Class II (US FDA 510(k))
by Mirus Llc
Identifiers
- 510(k) Number
- K180337 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 fixation device classified as a pedicle screw system under the FDA’s orthopedic product code NKB. It is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients, aiding in the treatment of acute and chronic spinal instabilities or deformities across the thoracic, lumbar, and sacral regions. The system includes pedicle screws and rods to facilitate spinal fusion procedures.
This device is supplied as a reusable surgical instrument set and is intended for use in controlled clinical environments such as operating rooms. It is not described as sterile or single-use in the submitted data. The system’s regulatory status includes a Traditional 510(k) clearance under the FDA’s Orthopedic (OR) Advisory Committee, with clearance number K180337. No MRI safety classification or specific storage requirements are stated in the provided specifications.
Frequently asked questions
What is the Europa Pedicle Screw System used for?
The Europa Pedicle Screw System is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients. It is intended for treating acute and chronic spinal instabilities or deformities across the thoracic, lumbar, and sacral regions, aiding in spinal fusion procedures.
Is the Europa Pedicle Screw System supplied sterile or single-use?
The Europa Pedicle Screw System is supplied as a reusable surgical instrument set. There is no indication in the provided data that it is sterile or intended for single-use, so it is meant for use in controlled clinical environments like operating rooms.
What regions of the spine can the Europa Pedicle Screw System address?
This system is specifically designed to address spinal stabilization needs in the thoracic, lumbar, and sacral regions, making it versatile for a range of spinal fusion procedures.
How is the Europa Pedicle Screw System regulated?
The Europa Pedicle Screw System holds a Traditional 510(k) clearance under the FDA’s Orthopedic (OR) Advisory Committee. It is classified under the orthopedic product code NKB and was granted clearance number K180337.
Are there any special storage requirements for the Europa Pedicle Screw System?
The provided specifications do not specify any particular storage requirements for the Europa Pedicle Screw System. Standard surgical instrument storage practices should be followed.
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, Europakarte - Karte von Europa - Europa Karte, EUROPA™ - SPINEMarketGroup, EUROPA Thoracolumbar Open and MIS Pedicle Screw System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180337 | Class II | Active |
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Manufacturer
- Manufacturer
- Mirus Llc
- FDA Applicant
- MiRus, LLC
Sources (1)
- FDA 510(k) K180337 24 fields · synced Oct 1, 2026