BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ULC SPINAL PEDICLE SCREW SYSTEM

    Reg #: 3005140381 · FEI: 3005140381 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OTIS BIOTECH CO., LTD
    Registration Number
    3005140381
    FEI Number
    3005140381
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #803,5, Heungdeok 2 –ro 105beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea
    City
    Yongin-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K083077

    Owner / Operator

    Firm Name
    OTIS BIOTECH CO., LTD
    Operator Number
    10031147
    Address
    803 5 Heungdeok 2 ro 105beon-gil Giheung-gu, Yongin-si Gyeonggi-do, Republic of Korea
    City
    Yongin-si
    State
    Gyeonggi
    Postal Code
    16953
    Country
    KR
    Correspondent
    Sanjay Lingot

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    ULC SPINAL PEDICLE SCREW SYSTEM

    Establishment Types

    Manufacture Medical Device