Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K213614
    Device Name
    Cannulated Screws
    Date Cleared
    2022-08-03

    (261 days)

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

    Maxxion Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Cannulated Screw and Double Compression Cannulated Screw are intended for the treatment of fractures, and arthrodesis of bones with the appropriate screw size. The Cannulated Compression Taper Screw (2.5-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. The Cannulated Compression Taper Screw (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, ostectomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula.
    Device Description
    Cannulated Screws are implantable medical devices developed for application in osteosynthesis, with the purpose of reducing, compressing, aligning, stabilizing, and fixing different types of fractures, in small, medium, and large bones, of lower and upper limbs, and can be used in isolated form or associated with washers. This submission also includes the corresponding washers for Cannulated Screws. The screws have a hexagonal connection for a wrench and can be found in three different models: Cannulated Screw, Double Compression Cannulated Screw and Cannulated Compression Taper Screw. These devices are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, being provided in non-sterile condition.
    Ask a Question

    Ask a specific question about this device

    K Number
    K181843
    Device Name
    MLP Special Locking Bone Plate System
    Date Cleared
    2019-03-04

    (236 days)

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

    Maxxion Medical, LLC / Baumer SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MLP Special Locking Bone Plate System is indicated for use in internal fixation for bone fractures, fusions, osteotomies, pseudoarthroses, and non-unions of the humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal and metatarsophalangeal in pediatrics and adult populations.
    Device Description
    The MLP Special Locking Bone Plate System consists of Bone Plates and locking screw components that are intended to be used in various bone fixation procedures. The MLP Special Locking Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium (Ti-6Al-4V) in conformance with ASTM F136. Plates and screws are provided non-sterile.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1