LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K220274
    Device Name
    Kisar Stratford SI Screw System
    Manufacturer
    Anjali Investments L.L.C
    Date Cleared
    2023-04-24

    (448 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anjali Investments L.L.C

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kisar Stratford SI Screw system is intended for fusion of the sacroillac joint for conditions including SI joint dysfunction resulting from SI joint disruption or degenerative sacroiliitis.
    Device Description
    The Kisar Stratford SI Screw System consists of threaded, fenestrated implant screws with a porous layer and an instrument system. The screws are inserted into the sacroiliac (SI) joint and intended to prevent and minimize motion of the joint thus promoting joint fusion. Bone graft material may be used in the fenestration of the implants as an additional means of promoting joint fusion. The screws are available in multiple diameters and lengths to accommodate different patient anatomy. All implants are fabricated from medical grade titanium alloy per ASTM F3001 and system instrumentation is manufactured from surgical grade stainless steel and other surgical grade materials.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1