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510(k) Data Aggregation

    K Number
    K033856
    Device Name
    5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN
    Manufacturer
    PETER STEVENS, MD
    Date Cleared
    2005-01-07

    (393 days)

    Product Code
    KTT,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This pediatric surgical implant is designed for the following intended purposes:

      1. To engage long bones including the femur, tibia, humerus, radius or ulna and permit the bone(s) to be secured to an external fixator or frame via a locking bolt.
      1. Thus to stabilize bone fragments to provide fracture alignment and stability; or
      1. Thus to stabilize bones that have been surgically cut in order to correct deformities including angular, rotational or length discrepancy.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (5.0mm and 6.0mm Cannulated Drill Pins), along with its Indications for Use. This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details required to answer your request regarding a study that proves the device meets acceptance criteria.

    The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring detailed performance studies against pre-defined acceptance criteria as would be typical for a novel device or a significantly different technology.

    Therefore, I cannot extract the requested information from the provided text.

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