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510(k) Data Aggregation

    K Number
    K050767
    Device Name
    STERLING INTERFERENCE SCREW ST
    Manufacturer
    REGENERATION TECHNOLOGIES, INC.
    Date Cleared
    2005-06-09

    (76 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The STERLING® Interference Screw ST is used to provide interference The STERENTO - and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft; fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.

    Device Description

    The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 15 to 40mm and diameters ranging from 7 to 10 mm. The STERLING® Interference Screw ST is threaded, has an internal hex-drive, and has a rounded proximal head.

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) premarket notification for the "STERLING® Interference Screw ST" and the FDA's response letter.

    The primary purpose of this document is to demonstrate "substantial equivalence" to predicate devices, not to present performance data against specific acceptance criteria.

    Therefore, I cannot provide the requested table and study information based on the provided text.

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