BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spinal Systems, LLC

    Reg #: 3017697442 · FEI: 3017697442 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    29
    Establishment Types
    3
    Classifications
    8

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    Registration Details

    Registration Name
    Spinal Systems, LLC
    Registration Number
    3017697442
    FEI Number
    3017697442
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8075 National Turnpike
    City
    Louisville
    State
    KY
    ZIP
    40214
    Country
    US

    Owner / Operator

    Firm Name
    Spinal Technology, LLC
    Operator Number
    9039913
    Address
    191 Mid Tech Drive, --
    City
    West Yarmouth
    State
    MA
    Postal Code
    02673
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Thigh Socket, External Component ISS
    Orthosis, Truncal/Orthosis, Limb MRI
    Medical Device Data System OUG
    Orthosis, Thoracic IPT
    Orthosis, Cervical-Thoracic, Rigid IQF
    Orthosis, Lumbo-Sacral IPY
    Monitor, Orthotic/Prosthetic NHF
    Orthosis, Lumbar IQE

    Proprietary Names

    Custom Transfemoral Check Socket Custom Transfemoral Definitive Socket Custom Transtibial Definitive Socket Custom Symes Check Socket Custom Symes Definitive Socket Custom Transtibial Check Socket Scoliosis/Kyphosis Orthosis Flex Foam 1 Low Profile with Custom Sternal Shield S.T.O.P. 1 TLSO Milwaukee Orthosis Full-Time Scoliosis Orthosis S.T.O.P. 4 Hip Orthosis Flex Foam 2 S.T.O.P. 3 S.T.O.P. 2 Flex Foam 3 Providence Nocturnal Scoliosis Orthosis SpinaLoc 2 stWear® Portal stWear® Smartphone App Pectus Brace CTLSO LSO SpinaLoc stWear® Compliance Monitor SpinaLoc 2 - Ultra Low Profile Orthosis

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility