BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SportCare

    Reg #: 3032314868 · FEI: 3032314868 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    SportCare
    Registration Number
    3032314868
    FEI Number
    3032314868
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    700 east Produce Rd
    City
    Hidalgo
    State
    TX
    ZIP
    78557
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203523

    Owner / Operator

    Firm Name
    Orthodoxo LLC
    Operator Number
    10091371
    Address
    3411 Silverside Rd
    City
    Wilmington
    State
    DE
    Postal Code
    19810
    Country
    US
    Correspondent
    Raul Solano

    Products

    Device Name Product Code
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Screw, Fixation, Bone HWC

    Proprietary Names

    ArthroRazor Blade ArthroRazor Bur AnchorFix Pk AnchorFix Ti AnchorFix Soft AnchorFix Knotless P+P AnchorFix Knotless P+T EasyStitch Gun ArthroScrew Pk ArthroScrew BIO

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility