AURORA Screw System
FDA 510(k)Class II (US FDA 510(k))
by Mirus Llc
Identifiers
- 510(k) Number
- K182989 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AURORA Screw System is intended to aid in the repair of fractures, fusions and osteotomies of bones and bone fragments. It features a low profile head, aggressive bone thread, and comes in a wide range of sizes. The screws are self-drilling and self-tapping with double lead thread and reverse flutes for removal.
The system is supplied as cannulated screws and is classified as a Screw, Fixation, Bone (product code HWC), Class II - Special Controls. It received FDA 510(k) clearance on December 18, 2018, after a review of 50 days. The device is manufactured by MiRus, LLC in Marietta, US.
Frequently asked questions
What is the AURORA Screw System used for?
The AURORA Screw System is intended to aid in the repair of fractures, fusions and osteotomies of bones and bone fragments. It features a low profile head and aggressive bone thread design for secure fixation.
How are the AURORA screws supplied and what are their key features?
The system is supplied as cannulated screws that are self-drilling and self-tapping with double lead thread and reverse flutes for easy removal. They come in a wide range of sizes to accommodate various clinical needs.
What is the regulatory status of the AURORA Screw System?
The AURORA Screw System received FDA 510(k) clearance on December 18, 2018, after a 50-day review. It is classified as a Class II device under product code HWC with Special Controls, manufactured by MiRus, LLC in Marietta, US.
Are the AURORA screws single-use or reusable?
The device data does not specify whether the AURORA screws are single-use or reusable. Clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal protocols for these screws.
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: AURORA™ Screws - MiRus, K182989 - AURORA Screw System | FDA 510(k) | MiRus, LLC, AURORA™ Screw System (K182989) — FDA 510 (k) | Innolitics, AURORA™ Screw System 510 (k) K182989 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182989 | Class II | Active |
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Manufacturer
- Manufacturer
- Mirus Llc
- FDA Applicant
- MiRus, LLC
Sources (1)
- FDA 510(k) K182989 24 fields · synced Sep 27, 2026