BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OPTIMOTION IMPLANTS, LLC

    Reg #: 3016470314 · FEI: 3016470314 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    OPTIMOTION IMPLANTS, LLC
    Registration Number
    3016470314
    FEI Number
    3016470314
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6052 Turkey Lake Road, Suite 170
    City
    Orlando
    State
    FL
    ZIP
    32819
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191084

    Owner / Operator

    Firm Name
    Optimotion Acquisition I, LLC
    Operator Number
    10095680
    Address
    6052 Turkey lake Rd, Suite 170
    City
    Orlando
    State
    FL
    Postal Code
    32819
    Country
    US

    Products

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

    Proprietary Names

    Optimotion Blue Total Knee System Optimotion Implants Porous Metal-Backed Patella The Optimotion™ Blue Plus Knee System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility