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510(k) Data Aggregation

    K Number
    K254045

    Validate with FDA (Live)

    Device Name
    CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
    Manufacturer
    CarboFix Orthopedics , Ltd.
    Date Cleared
    2026-03-16

    (89 days)

    Product Code
    NKG
    Regulation Number
    888.3075
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K240846,K243106,K252327,K233989,K163375
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K240846, K243106

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

    The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System is intended to provide immobilization and stabilization of spinal segments with anterior interbody support implanted at the same spinal level/s as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine and the upper thoracic spine (T1 to T3):

    • Traumatic spinal fractures and/or dislocations
    • Instability and deformity
    • Failed previous fusions (e.g., pseudarthrosis)
    • Degenerative disease, including intractable radiculopathy and/or myelopathy
    • Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
    • Degenerative disease of the facets with instability
    • Patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression

    The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System is intended to be used with anterior interbody support implanted at the same spinal level/s with autogenous and /or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

    Device Description

    CarboClear® Posterior Cervical Screw System ("CarboClear® System") and CarboClear® Hybrid Posterior Cervical Screw System ("CarboClear® Hybrid System") are composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.

    The screws incorporated into the systems are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with the CarboClear® Hybrid screws incorporating titanium alloy tulip. The screws threaded portion, and spherical head are encased within a thin titanium shell, and they may include a tantalum marker. The CarboClear® posterior cervical screws are used with CFR-PEEK set screw, and the CarboClear® Hybrid posterior cervical screws are used with a titanium alloy set screw. All screws are used with CarboClear® CFR-PEEK rods. CarboClear® titanium alloy rods are also offered.

    The implants are supplied sterile, and are intended for single use.

    AI/ML Overview

    N/A

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