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510(k) Data Aggregation

    K Number
    K982169
    Device Name
    SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    1998-09-14

    (87 days)

    Product Code
    MBI,DAT
    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 DRG Sherlock™ Threaded Anchor is for the fixation of nonabsorbable braided polyester surgical suture to bone for the indications listed below. WRIST/HAND Scapholunate ligament reconstruction Thumb ulnar collateral ligament reconstruction SKULL Endoscopic Brow lifts

    Device Description

    Sherlock™ TiN Coated Threaded Suture Anchors

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the "Sherlock™ Threaded Suture Anchor (TiN Coated)" and its associated indications for use. This document confirms the device's substantial equivalence to a predicate device but does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot extract the requested information from this document. The document is a regulatory approval, not a performance study report.

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