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Intramedullary Nail System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122994

by Weigao Orthopaedic Device Co., Ltd.

Identifiers

510(k) Number
K122994 FDA 510(k)
FDA Product Code
MNH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Intramedullary Nail System is an orthopedic device used for internal fixation of long bones. It is designed to provide stabilization and support for bone fractures by being inserted into the medullary canal of the bone.

This system is supplied as a sterile device and is intended for single-use. It is available in various sizes and models, including K122994. The device has received FDA 510(k) clearance with a determination of substantial equivalence to predicate device K053261 Orthofix.

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: INTRAMEDULLARY NAIL SYSTEM (K122994) — FDA 510(k) | Innolitics, INTRAMEDULLARY NAIL SYSTEM (K121312) — FDA 510(k) | Innolitics, Weigao Orthopaedic Device Co., Ltd. - FDA 510 (k) Cleared Devices, PDF Exhibit #1 510(k) Summary - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Weigao Orthopaedic Device Co., Ltd.

Sources (1)

  • FDA 510(k) K122994 24 fields · synced Sep 24, 2026