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510(k) Data Aggregation

    K Number
    K171624
    Device Name
    IXOS Radius Plate System
    Manufacturer
    Stuckenbrock Medizintechnik GmbH
    Date Cleared
    2018-03-29

    (300 days)

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

    Stuckenbrock Medizintechnik GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IXOS Radius Plate System is intended for surgical procedures in which internal fixation by implants is required for aligning, reconstruction and stabilizing bone tissue. It is used in particular for fixing intra- and extra articular acute fractures of the distal radius, in particularly - · Type A2 Colles fractures - · Type A3 fractures - · Type B1 fractures - · Type B2 Barton fractures - · Type B3 Smith or reversed Barton fractures - · Type C1 fractures - · Type C2 fractures - · Type C3 fractures and in osteotomies of the distal radius.
    Device Description
    The IXOS Radius Plate System is used for aligning, reconstructing and stabilizing bone tissue. It is used in the field of hand, accident and reconstructive surgery and orthopedics especially for the fixation of acute distal intra- and extra-articular fractures of the radius.
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    K Number
    K171628
    Device Name
    HBS2 Headless Bone Screw
    Manufacturer
    Stuckenbrock Medizintechnik GmbH
    Date Cleared
    2018-01-12

    (224 days)

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

    Stuckenbrock Medizintechnik GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HBS2 Headless Bone Screw is used for the treatment of intraarticular fractures and pseudoarthroses of smaller bones and bone fragments as well as for arthrodeses on small joints, especially in the scope of: HBS2 MIDI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Metatarsal fractures of the processus styloideus ulnae, Proximal radial head fractures HBS2 MINI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Fractures of the processus styloideus ulnae, Proximal radial head fractures of the processus styloideus radii
    Device Description
    The HBS2 Headless Bone Screws are used in the field of hand surgery, accident surgery and reconstructive surgery, and in orthopedics for the treatment of intraarticular and extra articular fractures and pseudo arthroses of small bone fragments, and for arthrodesis on small joints. The system consists of various screws and instruments for different treatment options. HBS2 screws are cannulated, self-drilling, self-cutting, have a reversing thread and are available in two diameters with different thread lengths. HBS2 MIDI screws (magenta) are available with a diameter of 2.0 mm (shaft) and in different lengths. HBS2 MINI screws (green) are available with a diameter of 1.7 mm (shaft) and in different lengths too. These devices are delivered in non-sterile condition and must be reprocessed before use. All implants are made out of Ti6Al4V 3.7165.
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    K Number
    K042902
    Device Name
    HERBERT ULNAR HEAD PROSTHESIS SYSTEM
    Manufacturer
    STUCKENBROCK MEDIZINTECHNIK GMBH
    Date Cleared
    2004-12-27

    (68 days)

    Product Code
    KXE
    Regulation Number
    888.3810
    Why did this record match?
    Applicant Name (Manufacturer) :

    STUCKENBROCK MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Herbert Ulnar Head Prosthesis System is indicated for ulnar head and stem replacement necessitated by: 1) Failed operative procedures such as Darrach, Bowers, or Sauve-Kapandji, 2) Primary osteoarthritis, 3) Post -traumatic osteoarthritis as a result of radial fractures, TFCC tears, ulnar impingement, 4) Rheumatoid arthritis, and 5) Tumors.
    Device Description
    The Herbert Ulnar Head Prosthesis System consists of an intramedullary ulnar stem made of titanium, a Co/Cr or Zirconia ulnar head, and a surgical instrumentation set.
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