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510(k) Data Aggregation

    K Number
    K250554
    Device Name
    prodisc® L Instruments
    Manufacturer
    Centinel Spine LLC
    Date Cleared
    2025-04-25

    (59 days)

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

    Centinel Spine LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.
    Device Description
    The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for four additional prodisc® L Instruments: - IN1575, Hemi Chisel +3mm, 10mm - IN1576, Hemi Chisel +3mm, 12mm - IN1570, Superior Impactor, Medium - IN1571, Superior Impactor, Large These are new instruments, based on similar devices within the existing instrument set.
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    K Number
    K242869
    Device Name
    prodisc® L Instruments
    Manufacturer
    Centinel Spine LLC
    Date Cleared
    2024-12-17

    (88 days)

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

    Centinel Spine LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.
    Device Description
    The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® L Instruments.
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    K Number
    K221848
    Device Name
    prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
    Manufacturer
    Centinel Spine LLC
    Date Cleared
    2022-08-19

    (56 days)

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

    Centinel Spine LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo instruments are intended for the placement, positioning, and removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices.
    Device Description
    The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments enable the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices to be implanted as a single unit into the disc space. Additional instruments are included to allow for the removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments.
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