BEUDAMED
    FDA Registration Active 🇨🇳 China

    Triathlon Knee System

    Reg #: 3005596372 · FEI: 3005596372 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD.
    Registration Number
    3005596372
    FEI Number
    3005596372
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 177 QINLING ROAD, XINBEI DISTRICT
    City
    CHANGZHOU, JIANGSU
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K141056

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH

    Proprietary Names

    Triathlon Knee System Triathlon Knee System Instrumentation

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)