Orthofix Galaxy Unyco Diaphyseal Tibia Kit
FDA 510(k)Class II (US FDA 510(k))
by Orthofix Srl
Identifiers
- 510(k) Number
- K142052 FDA 510(k)
- FDA Product Code
- KTT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Orthofix Galaxy Unyco Diaphyseal Tibia Kit is a medical device used for diaphyseal tibial fixation procedures. It is designed to provide stabilization and support for tibial fractures in the diaphyseal region.
The kit is supplied as a sterile, single-use device and is not intended for MRI environments. It is authorized under FDA 510K clearance with product code KTT and is manufactured by Orthofix Srl.
Frequently asked questions
What is the Orthofix Galaxy Unyco Diaphyseal Tibia Kit used for?
The Orthofix Galaxy Unyco Diaphyseal Tibia Kit is a medical device designed for diaphyseal tibial fixation procedures. It provides stabilization and support for tibial fractures specifically in the diaphyseal region of the tibia.
Is the Orthofix Galaxy Unyco Diaphyseal Tibia Kit reusable or single-use?
The kit is supplied as a sterile, single-use device and is not intended for reuse. It is designed for one-time use only to ensure patient safety and device integrity.
What regulatory authorization does the Orthofix Galaxy Unyco Diaphyseal Tibia Kit have?
The device is authorized under FDA 510K clearance with product code KTT. This indicates it has been determined to be substantially equivalent to predicate devices already on the market.
Can the Orthofix Galaxy Unyco Diaphyseal Tibia Kit be used in MRI environments?
No, the Orthofix Galaxy Unyco Diaphyseal Tibia Kit is not intended for MRI environments. It should only be used in settings where MRI compatibility is not required.
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 | K142052 | Class II | Active |
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Manufacturer
- Manufacturer
- Orthofix Srl
Sources (1)
- FDA 510(k) K142052 24 fields · synced Sep 23, 2026