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510(k) Data Aggregation

    K Number
    K102601
    Device Name
    ORTHOFLEX ROD
    Manufacturer
    ORTHO-PRO LLC
    Date Cleared
    2011-01-14

    (127 days)

    Product Code
    KWH
    Regulation Number
    888.3720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO-PRO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for the OrthoFlex Rod include: - Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis - Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis - Revision of a failed arthroplasty or arthrodesis
    Device Description
    The OrthoFlex Rod design is a double-stemmed flexible implant designed for the proximal interphalangeal joint of the lateral toes. It is made of silicone elastomer, and is constructed in a rod-shaped design with a thicker mid-section spacer or collar.
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    K Number
    K094037
    Device Name
    TC PLATING SYSTEM
    Manufacturer
    ORTHO-PRO LLC
    Date Cleared
    2010-03-10

    (70 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO-PRO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TC Plating System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
    Device Description
    The TC Plating System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplied with the system to facilitate implantation.
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    K Number
    K042310
    Device Name
    ORTHO-PRO CANNULATED BONE SCREWS
    Manufacturer
    ORTHO-PRO LLC
    Date Cleared
    2004-09-16

    (22 days)

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

    ORTHO-PRO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ortho-Pro Cannulated Bone Screws are indicated for bone fractures, osteotomies, artrhodeses, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
    Device Description
    The Ortho-Pro Cannulated Bone Screw consists of a threaded implant and corresponding instrumentation to facilitate insertion. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. These screws are of the self-tapping type. This device is manufactured from Ti-6A1-4V alloy and is available in a variety of sizes.
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    K Number
    K032682
    Device Name
    STS SCREW
    Manufacturer
    ORTHO-PRO LLC
    Date Cleared
    2003-10-22

    (54 days)

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

    ORTHO-PRO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ortho-Pro STS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions: - Severely pronated foot - Walking intemperance - Calcaneal stance position greater than 5° - Manually correctable deformities - Mid-tarsal breech (arch pain) - Forefoot varus greater than 10°
    Device Description
    The Ortho-Pro STS Screw consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. External rounded threads increase ease of insertion. This device is manufactured from Ti-6A1-4V alloy and is available in six sizes, 06.5mm to Ø11.5mm in 1mm increments.
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