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510(k) Data Aggregation

    K Number
    K231769
    Device Name
    activL® Next Generation Instrumentation
    Manufacturer
    Aesculap Implants Systems LLC
    Date Cleared
    2023-07-13

    (27 days)

    Product Code
    QLQ
    Regulation Number
    888.4515
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aesculap Implants Systems LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aesculap Implant Systems® activL® Next Generation Instrumentation are indicated for the successful implantation of the Aesculap activL® device. These instruments are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of the activL® device.
    Device Description
    The activl ® Next Generation Instrumentation would allow successful implantation of the Aesculap activL® device. These are manual surgical instruments which aid in selecting, placing, and revising the activL® device. These activL® instruments device comprises of trial, trial holders, single and double chisels, implant inserter, depth stop, depth stop driver, and impaction caps.
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