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510(k) Data Aggregation

    K Number
    K143450
    Device Name
    Ackermann Intervertebral Body Fusion Device
    Manufacturer
    ACKERMANN INSTRUMENTE GMBH
    Date Cleared
    2015-09-16

    (288 days)

    Product Code
    ODP, MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACKERMANN INSTRUMENTE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When used as a cervical intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device cispine implants are indicated for spinal fusion procedures in skeletally mature patients. Cervical interbody fusion implants are intended for use at one level in the cervical spine, from C2 to T1, for treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. Additionally, the clspine implants are to be used with autogenous bone graft and supplemental fixation via an open, anterior approach. When used as a lumbar intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device tispine implants are indicated for spinal fusion procedures in skeletally mature patients. Lumbar interbody fusion implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for treatment of lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. The tlspine implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implanted via a transforaminal approach. These implants are to be used with autogenous bone graft and supplemental fixation.
    Device Description
    Ackermann Intervertebral Body Fusion Device c|spine and t|spine is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from implant grade PEEK (polyetheretherketone, VESTAKEEP® i4 R bv Evonik).
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    K Number
    K111930
    Device Name
    ACKERMANN EUROPCLIP
    Manufacturer
    ACKERMANN INSTRUMENTE GMBH
    Date Cleared
    2011-11-08

    (124 days)

    Product Code
    FZP, MCH
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACKERMANN INSTRUMENTE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Europclip®is indicated for use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required. The device is intended to occlude the tubular structure by compression.
    Device Description
    The Europclip is a chevron-shaped clip having a heart-shaped cross-section and transverse grooves across the inner surface of the clip. The clips are supplied sterile, available in four sizes and pre-loaded in a disposable cartridge.
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    K Number
    K974382
    Device Name
    ACKERMANN SURGICAL INSTRUMENTS
    Manufacturer
    ACKERMANN INSTRUMENTE GMBH
    Date Cleared
    1998-04-21

    (151 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACKERMANN INSTRUMENTE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical procedures.
    Device Description
    The device is a line of general and minimally invasive surgical instruments and accessories.
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