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KangLi pedical screw spinal system

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K142290

by Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Identifiers

510(k) Number
K142290 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 KangLi Pedicle Screw Spinal System is a spinal fixation device designed for orthopaedic applications. It consists of pedicle screws and associated hardware used to stabilise the spine through internal fixation, facilitating surgical treatment of spinal deformities, fractures, or degenerative conditions.

This system is intended for use in orthopaedic surgical settings and is classified under the product code MNH. The pedicle screws are supplied sterile for single-use, adhering to regulatory standards including FDA 510(k) clearance and MDR compliance. Sizes and configurations are tailored for spinal fixation procedures, with sterility maintained through appropriate packaging and handling protocols.

Frequently asked questions

What types of spinal conditions is the KangLi Pedicle Screw Spinal System intended to address in surgical settings?

The KangLi Pedicle Screw Spinal System is designed for surgical stabilization of the spine in cases involving spinal deformities, fractures, or degenerative conditions. It provides internal fixation to support spinal alignment during orthopaedic procedures, ensuring stability while the spine heals.

Is the KangLi Pedicle Screw Spinal System meant for single-use or can it be reused after surgery?

The system is explicitly supplied sterile for single-use only, as outlined in its regulatory compliance (FDA 510(k) and MDR). Reuse is not recommended or supported due to sterility and safety standards.

How are the pedicle screws packaged and stored to maintain sterility before use?

The pedicle screws are packaged and handled according to strict sterility protocols to ensure they remain uncontaminated before surgery. The manufacturer adheres to regulatory standards, including FDA 510(k) clearance and MDR compliance, to guarantee sterile conditions for single-use applications.

What regulatory pathways does the KangLi Pedicle Screw Spinal System follow, and how does that affect its use?

The system follows the FDA 510(k) traditional clearance pathway (decision code SESE) and is MDR-compliant, meaning it meets U.S. and EU regulatory standards for spinal fixation devices. Clinicians can rely on its classification under product code MNH (orthopaedic spinal fixation) for surgical applications.

Are there different sizes or configurations available for the pedicle screws in this system?

Yes, the KangLi Pedicle Screw Spinal System offers tailored sizes and configurations specifically designed for spinal fixation procedures. These variations allow surgeons to select the appropriate hardware based on patient anatomy and clinical needs.

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: Orthopaedic Implant Manufacturer | Kangli Orthopaedics, Suzhoushi Kangli Orthopaedics Ienstrument CO.Ltd, Suzhou Kangli Orthopaedics Instrument Co., Ltd., KangLi pedical screw spinal system (K142290) — FDA 510 (k) | Innolitics, About Kangli Orthopaedics | China Manufacturer Since 2002

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Sources (2)

  • FDA 510(k) K142290 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026