Identifiers
- 510(k) Number
- K182785 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 VA Foot Plates 2.5 are orthopedic fixation devices designed for surgical applications in the fore- and midfoot. These plates are part of a plating system that combines fracture, fusion, and osteotomy stabilization, including revision options for metatarsophalangeal (MTP) plating and hook plates for fifth metatarsal fractures. They incorporate 2.5 mm locking and non-locking screws for secure internal fixation.
These plates are supplied sterile and intended for single-use in orthopedic procedures. They are regulated under FDA 510(k) clearance (K182785) as substantially equivalent to a predicate device, classified under the Orthopedic advisory committee. The plates are manufactured by aap Implantate AG and are distributed with appropriate packaging for surgical settings, adhering to standard medical device sterility and handling protocols.
Frequently asked questions
What are the LOQTEQ VA Foot Plates 2.5 used for?
These orthopedic fixation devices are designed for surgical applications in the fore- and midfoot, providing stabilization for fractures, fusions, and osteotomies, including revision options for MTP plating and fifth metatarsal fractures.
How are the LOQTEQ VA Foot Plates 2.5 supplied?
The plates are supplied sterile and intended for single-use in orthopedic procedures, distributed with appropriate packaging for surgical settings following standard medical device sterility protocols.
What type of screws are compatible with these plates?
The LOQTEQ VA Foot Plates 2.5 incorporate both 2.5 mm locking and non-locking screws to ensure secure internal fixation during orthopedic procedures.
What is the regulatory status of these plates?
The plates are regulated under FDA 510(k) clearance (K182785) as substantially equivalent to a predicate device, classified under the Orthopedic advisory committee.
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 Implants Inc | Foot System 2.5, aap Implantate AG | LOQTEQ® Plating System, LOQTEQ VA Foot Plates 2.5 - healthcareequipment.org
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182785 | Class II | Active |
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Manufacturer
- Manufacturer
- aap Implantate AG
Sources (1)
- FDA 510(k) K182785 24 fields · synced Oct 6, 2026