LOQTEQ Distal Dorsolateral Humerus Plate
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132787 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 LOQTEQ Distal Dorsolateral Humerus Plate is a locked orthopedic plate designed for internal fixation of distal humerus fractures. It is classified as a Distal Humerus Plate under orthopedic nomenclature, featuring a dorsolateral approach for stabilization of complex fractures. Constructed with locking screws, it ensures secure fixation to the bone, promoting anatomical alignment and fracture healing. The plate is engineered to accommodate varying fracture patterns, including comminuted or displaced fractures of the distal humerus.
This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is compatible with MRI environments, as specified in its regulatory submission. Available in sizes 2.7 and 3.5, the plate is part of the LOQTEQ Plating System and requires surgical instrumentation for application, including drill guides and locking screws. Authorized under FDA 510K clearance (K132787), it adheres to traditional orthopedic fixation principles for distal humerus reconstruction. Storage instructions and full technical details are outlined in the accompanying surgical manual.
Frequently asked questions
What is the LOQTEQ Distal Dorsolateral Humerus Plate used for?
This plate is designed for internal fixation of distal humerus fractures, particularly complex or comminuted cases. Its dorsolateral approach and locking screw system provide stable alignment to support anatomical healing, making it suitable for displaced or fragmented fracture patterns.
How is the LOQTEQ Distal Dorsolateral Humerus Plate supplied and intended for use?
The plate is supplied sterile and intended for single-use in orthopedic surgical settings. It requires specialized instrumentation, including drill guides and locking screws, for proper application. The accompanying surgical manual includes detailed instructions for use.
What sizes are available for the LOQTEQ Distal Dorsolateral Humerus Plate?
The plate is available in two sizes: 2.7 and 3.5. These sizes accommodate different fracture patterns and anatomical variations, ensuring flexibility in surgical planning for distal humerus reconstruction.
Is the LOQTEQ Distal Dorsolateral Humerus Plate compatible with MRI environments?
Yes, the device is explicitly designed to be MRI-compatible, as noted in its regulatory submission. This feature allows for safe postoperative imaging without interference from the fixation hardware.
How should the LOQTEQ Distal Dorsolateral Humerus Plate be stored?
Storage instructions are detailed in the surgical manual provided with the device. Proper storage ensures sterility and functionality, including protection from moisture, extreme temperatures, and physical damage.
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: AAP LOQTEQ Distal Dorsolateral Humerus Plate 2.7/3.5 Manual, aap Implantate AG | LOQTEQ® Plating System, AAP LOQTEQ Distal Dorsolateral Humerus Plate 2.7/3.5 Manuals
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132787 | Class II | Active |
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Manufacturer
- Manufacturer
- aap Implantate AG
Sources (1)
- FDA 510(k) K132787 24 fields · synced Oct 5, 2026