BEUDAMED
    FDA Registration Active 🇨🇳 China

    G7 Acetabular System Item # 010001042

    Reg #: 3004748528 · FEI: 3004748528 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    SHANGHAI JPY ION-TECH CO., LTD.
    Registration Number
    3004748528
    FEI Number
    3004748528
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K121874

    Owner / Operator

    Firm Name
    SHANGHAI JPY ION-TECH CO., LTD.
    Operator Number
    9066119
    Address
    NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE
    City
    SHANGHAI
    State
    CN-NOTA
    Postal Code
    201707
    Country
    CN

    US Agent

    Business Name
    MANTON BUSINESS & TECHNOLOGY SERVICES, LLC
    Contact Name
    Charles Shen
    Address
    37 Winding Rdg
    City
    Oakland
    State
    NJ
    ZIP
    07436
    Country
    US
    Email
    [email protected]
    Phone
    608 2179358

    Products

    Device Name Product Code
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    G7 Acetabular System Item # 010001042 G7 Acetabular System Item # 010001037 G7 Acetabular System Item # 010001034 G7 Acetabular System Item # 010001032 G7 Acetabular System Item # 010001040 G7 Acetabular System Item # 010001039 G7 Acetabular System Item # 010001033 G7 Acetabular System Item # 010001044 G7 PP S LTD ACET SHELL 54F Item # 010000664 G7 PPS LTD ACET SHELL 58G Item # 010000666 G7 Acetabular System Item # 010001031 G7 Acetabular System Item # 010001035 G7 Acetabular System Item # 010001043 G7 Acetabular System Item # 010001041 G7 PPS LTD ACET S HELL 66I Item # 010000670 G7 Acetabular System Item # 010001038 G7 Acetabular System Item # 010001036 G7 PPS LTD ACET SHELL 46B Item # 010000660 G7 PPS LTD ACET SHELL 44A Item # 010000659 G7 PPS LTD ACET SHELL 62H Item # 010000668 G7 PPS LTD ACET SHELL 60G Item # 010000667 G7 PPS LTD ACET SHELL 64H Item # 010000669 G7 PPS LTD ACET SHELL 48C Item # 010000661 G7 PPS LTD ACET SHELL 42A Item # 010000658 G7 PPS LTD ACET SHELL 56F Item # 010000665 G7 PPS LTD ACET SHELL 68I Item # 010000671 G7 PPS LTD ACET SHELL 50D Item # 010000662 G7 PPS LTD ACET SHELL 52E Item # 010000663

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)