BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    ZIMMER CAS

    Reg #: 9617840 · FEI: 3003714383 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    46
    Establishment Types
    2
    Classifications
    24

    Registration Details

    Registration Name
    ZIMMER CAS
    Registration Number
    9617840
    FEI Number
    3003714383
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    75 QUEEN ST., SUITE 3300
    City
    MONTREAL, QUEBEC
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K131409

    Owner / Operator

    Firm Name
    ZIMMER, INC.
    Operator Number
    1822565
    Address
    345 E. Main Street, --
    City
    Warsaw
    State
    IN
    Postal Code
    46580
    Country
    US

    US Agent

    Business Name
    Zimmer Biomet
    Contact Name
    Stephanie Lynch
    Address
    1800 W Center St
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    715 9289253

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Knee Arthroplasty Implantation System OOG
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Shoulder Prosthesis, Reverse Configuration PHX
    Shoulder Arthroplasty Implantation System QHE
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Orthopedic Stereotaxic Instrument OLO
    System, Image Processing, Radiological LLZ
    Orthopedic Augmented Reality SBF
    System, X-Ray, Film Marking, Radiographic JAC
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Intraoperative Orthopedic Joint Assessment Aid ONN
    Motor, Surgical Instrument, Ac-Powered GEY
    Neurological Stereotaxic Instrument HAW
    Instrument, Quality-Assurance, Radiologic LHO
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Orthopaedic Surgical Planning And Instrument Guides PBF
    Orthopedic Manual Surgical Instrument LXH
    Tray, Surgical, Instrument FSM
    Battery, Replacement, Rechargeable MOQ

    Proprietary Names

    CAS PSI Knee System Zimmer PSI Knee Signature™ ONE System Rosa Knee System OptiVu™ ROSA® Mixed Reality OptiVu™ ROSA® MxR ROSA Shoulder System X-Ray Calibration Strap Long and Short Signature ONE System-Shoulder Signature ONE System X-PSI Knee System ELIBRA DYNAMIC KNEE BALANCER Efficient Care 3D Planning ROSA® Hip System Zimmer Biomet X Series HAMMR Navitrack CT-Free Navitrack OS Knee Universal X-Ray Marker Navitrack S&N Image Free Hip Navitrack-CT Free Cup Navitrack Optical TKR CT-Less ONE Planner Hip ROSA Hip System Navitrack-FluoroSpine ROSA® Knee System CAS Fixation Pins Navitrack OS Unicond Knee Universal Zimmer PSI Shoulder CAS PSI Shoulder iASSIST Knee System Navitrack CT-Based ROSA Knee System PSN Valgus Alignment Guide Navitrack-Optical Option Zimmer PSI Shoulder System Universal Sterilization Case RETRACTOR CASE Various Trays ROSA Partial Knee System Universal Funnel for Aseptic Transfer Kit Universal Battery for Aseptic Transfer Kit Universal Flash Battery Universal Compact Battery Charger Universal Complete Aseptic Transfer Kit with Battery ELIBRA SOFT-TISSUE FORCE SENSOR

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility