Universal Distal Radius System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130774 FDA 510(k)
- FDA Product Code
- HRS 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 Universal Distal Radius System is a range of orthopedic implants designed for the treatment of hand and forearm fractures, osteotomies, and arthrodeses in adults. These devices are specifically engineered for the distal radius and ulna to facilitate bone stabilization and healing.
This system is supplied as single-use sterile kits and is classified as a Class II medical device in the United States. The implants are intended to be handled and implanted by trained professionals. The device has received FDA 510k clearance.
Frequently asked questions
What is the intended use of the Universal Distal Radius System?
This system is designed for the treatment of fractures, osteotomies, and arthrodeses of the distal radius and ulna in adults. It provides the necessary bone stabilization to facilitate the healing process.
Is the Universal Distal Radius System intended for reuse?
No, the system is supplied as single-use sterile kits. This ensures that each implant remains sterile and maintains its structural integrity for the patient, eliminating the risks associated with reprocessing and sterilization of used implants.
Who is authorized to use these orthopedic implants?
These devices are intended to be handled and implanted exclusively by trained medical professionals. This requirement ensures that the implants are placed correctly to achieve optimal clinical outcomes for fracture stabilization.
What is the regulatory status of this device?
The Universal Distal Radius System is classified as a Class II medical device in the United States and has received FDA 510k clearance under the number K130774.
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: Xpert Wrist - plates for the Wrist - Newclip Technics, PDF Initial R Xpert 2.4: Single use distal radius sterile kits, PDF XPERT WRIST X - newcliptechnics.us, PDF XPERT WRIST X - newcliptechnics.us
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130774 | Class II | Active |
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Manufacturer
- Manufacturer
- Newclip Technics
Sources (1)
- FDA 510(k) K130774 24 fields · synced Sep 26, 2026