TriMed Volar Bearing Plates (VBEAL-13-7S) +5 more models
FDA 510(k)Class II (US FDA 510(k))
by Trimed, INC.
Identifiers
- 510(k) Number
- K254002 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
- Models / Variants
- TriMed Volar Bearing Plates (VBEAL-13-7S) FDA 510(k)TriMed Volar Bearing Plates (VBEAR-13-7S) FDA 510(k)TriMed Volar Bearing Plates (VBEAL-14-7S) FDA 510(k)TriMed Volar Bearing Plates (VBEAR-14-7S) FDA 510(k)TriMed Volar Bearing Plates (VBEAL-16-7S) FDA 510(k)TriMed Volar Bearing Plates (VBEAR-16-7S) 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)
TriMed Volar Bearing Plates are metallic bone fixation implants designed to provide constraint of movement for fractured or osteotomized radius bones during the healing process. They offer up to 36° angular range and maintain optimal plate positioning to achieve subchondral support.
The plates are supplied in various sizes including VBEAL-13-7S, VBEAR-13-7S, VBEAL-14-7S, VBEAR-14-7S, VBEAL-16-7S, and VBEAR-16-7S. They are manufactured by TriMed, Inc. and have received FDA 510(k) clearance with the product code HRS. The device is intended for use in orthopedic applications and has been classified as substantially equivalent.
Frequently asked questions
What are TriMed Volar Bearing Plates used for?
TriMed Volar Bearing Plates are metallic bone fixation implants designed to provide constraint of movement for fractured or osteotomized radius bones during the healing process. They maintain optimal plate positioning to achieve subchondral support.
What sizes are available for TriMed Volar Bearing Plates?
The plates are supplied in various sizes including VBEAL-13-7S, VBEAR-13-7S, VBEAL-14-7S, VBEAR-14-7S, VBEAL-16-7S, and VBEAR-16-7S, allowing for appropriate selection based on patient anatomy and surgical requirements.
What is the regulatory status of TriMed Volar Bearing Plates?
TriMed Volar Bearing Plates have received FDA 510(k) clearance with the product code HRS and have been classified as substantially equivalent. They are intended for use in orthopedic applications.
What is the angular range provided by TriMed Volar Bearing Plates?
TriMed Volar Bearing Plates offer up to 36° angular range, which allows for controlled movement while maintaining optimal plate positioning to achieve subchondral support during the healing process.
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: TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates ..., Volar Plates - TriMed Inc, K254002 - TriMed Volar Bearing Plates (VBEAL-13-7S), TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K254002 | Class II | Active |
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Manufacturer
- Manufacturer
- Trimed, INC.
Sources (1)
- FDA 510(k) K254002 24 fields · synced Oct 6, 2026