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510(k) Data Aggregation

    K Number
    K071549
    Device Name
    SBI RHEAD PLATING SYSTEM
    Manufacturer
    SMALL BONE INNOVATIONS INC.
    Date Cleared
    2007-08-07

    (62 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SBI RHEAD PLATING SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SBi rHead Plating System is indicated for fractures of the proximal radius.

    Device Description

    The SBi rHead Plating System consists of various plates and screws to treat fractures of the proximal radius. SBi plans to offer two plate designs: the rHead Neck Plate and the rHead Rim Plate. Both have a curved, T-shaped design to match the geometry of the proximal radius. Both will be available in a variety of neck widths, plate lengths, and hole geometries (threaded and non-threaded). Locking and non-locking screws will be included as part of the SBi rHead Plating System.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (SBi rHead Plating System). It is a regulatory submission for market clearance and does not contain information about acceptance criteria or a study proving that the device meets such criteria.

    The document primarily focuses on:

    • Device Description: The SBi rHead Plating System consists of plates and screws for proximal radius fractures.
    • Intended Use: Fractures of the proximal radius.
    • Material: Stainless steel.
    • Substantial Equivalence: The manufacturer claims the device is substantially equivalent to other legally marketed devices, which is the basis for 510(k) clearance.

    Therefore, I cannot provide the requested information from the given text as it is not present in the document. This type of submission relies on demonstrating similarity to existing devices, rather than presenting clinical or performance data against specific acceptance criteria.

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