Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K002324
    Device Name
    MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
    Manufacturer
    SULZER MEDICA
    Date Cleared
    2000-08-24

    (24 days)

    Product Code
    JDI, KRO, LZO
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER MEDICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K993667
    Device Name
    SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
    Manufacturer
    SULZER MEDICA
    Date Cleared
    2000-01-28

    (88 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER MEDICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sulzer Vascutek SEALPTFE™ grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels. Typical applications for standard wall grafts include systemic vascular repair, primarily for axillo-femoral/bifemoral bypass and femoral-popliteal reconstruction. Typical applications for thin wall grafts include systemic vascular repair, but not for axillo-femoral/bifemoral bypass reconstruction.
    Device Description
    The Sulzer Vascutek SEALPTFE™ gelatin-sealed expanded polytetrafluoroethylene (PTFE) graft line is composed of PTFE, which has been fabricated in tubular form and expanded to impart porosity to the structure. The PTFE material has been impregnated with an absorbable mammalian gelatin that is intended to reduce intraoperative suture hole bleeding. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The gelatin used in the impregnation process is a non-antigenic and non-toxic protein. It has been crosslinked to control its dissolution rate. The gelatin hydrolyzes within approximately 14 days. The gelatin is identical to that used with Sulzer Vascutek's gelatin-sealed knitted and woven polyester grafts and knitted cardiovascular fabric.
    Ask a Question
    K Number
    K993569
    Device Name
    APR METASUL ACETABULAR INSERT
    Manufacturer
    SULZER MEDICA
    Date Cleared
    1999-12-01

    (41 days)

    Product Code
    KWA
    Regulation Number
    888.3330
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER MEDICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APR Metasul Acetabular Inserts are intended for use with the APR Acetabular Shells and Metasul femoral heads in total hip arthroplasty for treatment of the following: - patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular ● necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - those patients with failed previous surgery where pain, deformity, or dysfunction persists. . - revision of a previously failed arthroplasty. .
    Device Description
    The APR Metasul Acetabular Insert is a modular metal insert which is hemispherical in shape and has an outer diameter manufactured from polyethylene (UHMWPE, ASTM F648). The outer diameter of the insert is machined with locking features that mate with one of the previously cleared APR metallic acetabular shells. The inner diameter which forms the bearing surface of this insert features a metallic Metasul inlay that is integrally locked to the polyethylene portion. The metal inlay is manufactured from Protasul"-21WF, a wrought forged CoCrMo alloy (ISO 5832-4, ISO 5832-12). This inlay is polished to a mirror-finish and hot-pressed into the UHMWPE backing. Just prior to hot-pressing, two Protasul-10 (CoCr alloy, ASTM F562) pins may be press fit into the design of the inlay to help provide added rotational stability. As a result of the strictly controlled tolerances of the inlay and in order to recognize the beneficial wear properties associated with this component, this insert is designed for use only with previously cleared head components. The APR Metasul Acetabular Insert component is available with outside diameters of 49mm to 81mm (in 2mm increments) with an inner diameter of 28mm.
    Ask a Question
    K Number
    K992832
    Device Name
    SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
    Manufacturer
    SULZER MEDICA
    Date Cleared
    1999-11-19

    (88 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER MEDICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sulzer Vascutek ePTFE grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels.
    Device Description
    The device is composed of polytetrafluoroethylene, which has been fabricated in tubular form and expanded to impart porosity to the structure.
    Ask a Question

    Page 1 of 1