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510(k) Data Aggregation

    K Number
    K190543
    Device Name
    Cannulated Hemi Implant
    Manufacturer
    Vilex in Tennessee, Inc.
    Date Cleared
    2019-05-31

    (88 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vilex in Tennessee, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vilex CHI (cannulated hemi implant), a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with bone cement. The Vilex cannulated metallic hemi implant is intended for single-use only.
    Device Description
    The Vilex CHI System includes one-piece cannulated hemi-arthroplasty implants intended to resurface the metatarsal-phalangeal joint. The CHI system includes an MPJ Base and MPJ Head. These are available in standard and lesser options. These components are used for hemi arthroplasty and are not used together to create a total joint.
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    K Number
    K150211
    Device Name
    EzFuze Implant System
    Manufacturer
    VILEX IN TENNESSEE, INC.
    Date Cleared
    2015-11-10

    (284 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    VILEX IN TENNESSEE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EzFuze Implants have the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.
    Device Description
    The Vilex EzFuze Implant System includes single-piece devices intended for the fixation of PIP joints in lesser toes and digits. Two styles are offered: EzFuze Implant with barbed prongs on both ends and Hybrid EzFuze Implant with a screw design at one end and the other end includes barbed prongs. The EzFuze and Hybrid EzFuze Implants are offered straight or with a 10° bend.
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    K Number
    K141937
    Device Name
    TRIDENT FUSION IMPLANT
    Manufacturer
    VILEX IN TENNESSEE, INC.
    Date Cleared
    2014-09-10

    (55 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    VILEX IN TENNESSEE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trident Fusion Implant has the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.
    Device Description
    The Vilex Trident Fusion Implant is a single-piece cannulated bone screw intended for the fixation of PIP joints in lesser toes and digits. The device is offered straight or with a 10° bend at the joint. It is available in either stainless steel or titanium.
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