Reprocessed Dyonics Arthroscopic Burs
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K012652 FDA 510(k)
- FDA Product Code
- HRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.1100 FDA 510(k)
- Regulation Number
- 888.1100 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Reprocessed Dyonics Arthroscopic Burs are medical devices used in arthroscopic procedures for bone and tissue removal. These burs are designed to be compatible with arthroscopic systems and are intended for use in orthopedic surgeries.
The device is reprocessed and supplied as a single-use or reusable product, depending on the specific model. It is authorized under FDA 510K clearance with product code HRX and is available in various sizes as specified by the manufacturer. The device is stored according to the manufacturer's instructions and is intended for use in sterile environments.
Frequently asked questions
What are Reprocessed Dyonics Arthroscopic Burs used for?
These burs are medical devices designed for use in arthroscopic procedures to remove bone and tissue during orthopedic surgeries. They are compatible with arthroscopic systems and intended for sterile environments.
Are these burs single-use or reusable?
The Reprocessed Dyonics Arthroscopic Burs can be supplied as either single-use or reusable products, depending on the specific model selected by the healthcare provider.
What sizes are available for these arthroscopic burs?
The burs are available in various sizes as specified by the manufacturer, allowing surgeons to select the appropriate size for different surgical requirements and anatomical considerations.
How should these devices be stored?
The Reprocessed Dyonics Arthroscopic Burs should be stored according to the manufacturer's instructions to maintain their integrity and functionality until use in sterile environments.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012652 | Class II | Active |
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Manufacturer
- Manufacturer
- Alliance Medical, Inc.
- FDA Applicant
- Alliance Medical Corp.
Sources (1)
- FDA 510(k) K012652 24 fields · synced Oct 6, 2026