BEUDAMED
    FDA Registration Active 🇨🇳 China

    K043151

    Reg #: 3020282716 · FEI: 3020282716 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    APS Materials Suzhou
    Registration Number
    3020282716
    FEI Number
    3020282716
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building # 2, Emerging Industrial Square, 78 Xinglin Street, Suzhou Industrial Park
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K043151

    Owner / Operator

    Firm Name
    APS Materials, Inc
    Operator Number
    9023611
    Address
    4011 Riverside Dr, Dayton OH
    City
    Dayton
    State
    OH
    Postal Code
    45405
    Country
    US
    Correspondent
    Chris Page

    US Agent

    Business Name
    APS MATERIALS, INC
    Contact Name
    Christopher Page
    Address
    4011 RIVERSIDE DR., --
    City
    Dayton
    State
    OH
    ZIP
    45405
    Country
    US
    Email
    [email protected]
    Phone
    937 2786547 ext. 249

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    K043151

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)