BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ANATOMICAL Rasp for humeral stem 10.5

    Reg #: 3010314800 · FEI: 3010314800 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INNOTOOL&GREMINGER AG
    Registration Number
    3010314800
    FEI Number
    3010314800
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Fabrikstrasse 1E
    City
    Erlen Thurgau
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K103404

    Owner / Operator

    Firm Name
    innotool & greminger ag
    Operator Number
    10043239
    Address
    Fabrikstrasse 1E
    City
    Erlen
    State
    Thurgau
    Postal Code
    8586
    Country
    CH
    Correspondent
    Enver Memeti

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    ANATOMICAL Rasp for humeral stem 10.5 AS B/F Silhouette 45° AS B/F Resection guide 45° ANATOMICAL Rasp for humeral stem 9 AS B/F Resection guide 48° ANATOMICAL Rasp for humeral stem 7 ANATOMICAL Rasp for humeral stem 12 AS B/F Resection guide 42° AS B/F Extractor Instrument for Adaptor AS B/F Cutting guide 45° ANATOMICAL Rasp for humeral stem 14

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)