Identifiers
- 510(k) Number
- K230690 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 Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws.
The system is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia. It is cleared under FDA 510(k) K230690 with product code HRS and classified under the Orthopedic advisory committee.
Frequently asked questions
What is the Tandry Locking Plate System used for?
The Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula, and calcaneal; small bones such as metatarsals, tarsals, and phalanges; and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
What types of screws can be used with the Tandry Locking Plate System?
The plates in the Tandry Locking Plate System are designed to accept locking, cortex, shaft, and cancellous screws, allowing flexibility in fixation based on bone quality and surgical needs.
Is the Tandry Locking Plate System supplied sterile or non-sterile?
The device data does not specify whether the Tandry Locking Plate System is supplied sterile or non-sterile, so sterility status cannot be confirmed from the provided information.
What is the regulatory pathway for the Tandry Locking Plate System?
The Tandry Locking Plate System is cleared under FDA 510(k) submission K230690 and is classified under the Orthopedic advisory committee with product code HRS.
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: PDF 005_510(k) Summary.pdf - Food and Drug Administration, Tandry Locking Plate System (K171904) — FDA 510(k) | Innolitics, Microware Precision Co., Ltd. FDA 510(k) Products - Latest 2024, K230690 FDA 510 (k) - Tandry Locking Plate System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230690 | Class II | Active |
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Manufacturer
- Manufacturer
- Microware Precision Co., Ltd.
Sources (1)
- FDA 510(k) K230690 24 fields · synced Oct 1, 2026