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510(k) Data Aggregation

    K Number
    K030302
    Device Name
    HBS HEADLESS BONE SCREW
    Manufacturer
    SCHOENING & ASSOC., INC.
    Date Cleared
    2003-08-08

    (191 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOENING & ASSOC., INC.

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

    Headless bone screw system for the fixation of osseous fragments or fractures including:

    HBS - MINI: Scaphoid fractures, Lunate fractures, Capitate, Trapezial fractures, Metacarpal and metatarsal fractures, Phalangeal fractures, Radial head fractures, Ulnar styloid fractures, Osteo-chrondral, Small joint fusions

    HBS - STANDARD: Scaphoid fractures, Carpal fractures & non-unions, Capitellum fractures, Metacarpal fractures, Phalangeal fractures, Distal radial fractures, Radial head fractures, Ulnar styloid fractures, Small joint fusions, Humeral head fractures, Glenoid fractures, Intercarpal fusions, Interphalangeal fractures, Metatarsal osteotomies, Tarsal fusions, Malleolar fractures, Patellar fractures, Osteo-chrondral fractures, Odontoid fractures, Mandibular fractures

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the HBS Headless Bone Screw. It does not contain any information about acceptance criteria or a study proving device performance in relation to such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended indications for use.

    Therefore, I cannot provide the requested information.

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