Versalock Upper Limb Plating System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243740 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 Versalock Upper Limb Plating System is a system of anatomical plates with variable angle locking holes for fixation, reconstruction, treatment and stabilization of the bones and joints of the upper limb. It is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna.
The system comprises metallic bone plates and screws for trauma and reconstructive surgery. It is supplied as a sterile device and is intended for single-use. The Versalock Upper Limb Plating System has received FDA 510(k) clearance with product code HRS and K-number K243740.
Frequently asked questions
What is the Versalock Upper Limb Plating System used for?
The Versalock Upper Limb Plating System is used for internal bone fixation in trauma and reconstructive surgery, specifically for bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna.
Is the Versalock Upper Limb Plating System reusable?
No, the Versalock Upper Limb Plating System is supplied as a sterile device and is intended for single-use only.
What components make up the Versalock Upper Limb Plating System?
The system comprises metallic bone plates and screws designed for fixation, reconstruction, treatment, and stabilization of bones and joints in the upper limb.
What regulatory clearance has the Versalock Upper Limb Plating System received?
The Versalock Upper Limb Plating System has received FDA 510(k) clearance with product code HRS and K-number K243740.
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: Versalock Upper Limb Plating System (K243740) - FDA 510 (k), Versalock Upper Limb Plating System (K243740) - Innolitics, PDF anexo - gmreis.com.br, K260390 - Super Upper Limbs Versalock Plating System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243740 | Class II | Active |
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Manufacturer
- Manufacturer
- Gm Dos Reis Industria E Comercio Ltda
- FDA Applicant
- GM Dos Reis Industria e Comercio Ltda.
Sources (1)
- FDA 510(k) K243740 24 fields · synced Sep 19, 2026