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510(k) Data Aggregation

    K Number
    K982886
    Device Name
    OTI MODULAR SHOULDER SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    1998-10-05

    (49 days)

    Product Code
    HSD
    Regulation Number
    888.3690
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Prosthetic replacement with the OTI Modular Shoulder System (Hemi humeral component)may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the shoulder joint; non-union in humeral head fractures of long duration; avascular necrosis of the humeral hcad, traumatic fractures of the humerus and/ or other difficult clinical management problems.

    Device Description

    OTI Modular Shoulder System (Hemi humeral component)

    AI/ML Overview

    Given the provided text, there is no information regarding acceptance criteria, device performance, or any studies proving the device meets specific criteria.

    The document is a 510(k) clearance letter from the FDA, indicating that the OTI Modular Shoulder System has been found substantially equivalent to a predicate device. It specifies the product code, regulatory class, and indications for use.

    Therefore, I cannot provide answers to your specific questions as the relevant information is not present in the given text.

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