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510(k) Data Aggregation

    K Number
    K102577
    Device Name
    FORCE MEDICAL IM NAIL SYSTEM
    Manufacturer
    Date Cleared
    2012-05-03

    (603 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORCE MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Force Medical IM Nail is intended for tibiotalocalcaneal (TTC) arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Indications for use include: - Posttraumatic and primary Arthrosis - Neuromuscular deformity - Revision of Failed Ankle Arthrodesis - Failed Total Ankle Replacement - Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis) - A Neuroarthropathy (Charcot) - Rheumatoid Arthritis with severe deformity - Osteoarthritis - Pseudarthrosis
    Device Description
    The Force Medical IM Nail System is an angled (left & right) and straight (left & right due to hole orientation), cannulated, intramedullary nail in multiple diameters(8) and in multiple lengths(3) manufactured from High Strength 6-4 Titanium Alloy to ASTM F136. The nail features proximal, distal, and midshaft angled hole(s) to receive Alloyed Titanium transverse locking 4.5mm Cortical and 4.5/6.5 Transition Cortical - Cancellous Bone Screws (in various lengths). Endcaps (in 0+ and 6 lengths in 4 diameters) in the Titanium Alloy are available for nail end bottom screw locking and IM Nail length extension. A Titanium Alloy Compression Washer and Screw (in 5 lengths) is also available for joint compression(s) if distal talocalcaneal fusion is required. All alloyed titanium components have a Type II anodize surface treatment and are anodize color coded for left/right versions. A full set of guide/placement instrumentation is available for accurate placement and alignment of the bone screws within the nail when used in conjuction with x-ray fluoroscopy.
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    K Number
    K081603
    Device Name
    DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
    Date Cleared
    2009-07-24

    (413 days)

    Product Code
    Regulation Number
    870.2320
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEARTFORCE MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The dBG 300 records vibrational waveforms produced by the hearts contractions and transmitted to the chest wall. The dBG 300 may be used as a tool to measure the timing of the events in the cardiac cycle.
    Device Description
    The Heart Force Ballistocardiograph senses and analyzes the mechanical movement of the heart. This is accomplished with 2 or 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motion.
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