BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    ARVATO Netherlands B.V.

    Reg #: 3013302242 · FEI: 3013302242 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    36

    Registration Details

    Registration Name
    ARVATO Netherlands B.V.
    Registration Number
    3013302242
    FEI Number
    3013302242
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Brem 1
    City
    Heijen Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K073375

    Owner / Operator

    Firm Name
    Arvato Netherlands B.V.
    Operator Number
    10077655
    Address
    Brem 1
    City
    Heijen
    State
    Limburg
    Postal Code
    6598
    Country
    NL
    Correspondent
    Senta Valenteyn

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Tray, Surgical, Instrument FSM
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Rod, Fixation, Intramedullary And Accessories HSB
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Pin, Fixation, Smooth HTY
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Neurological Stereotaxic Instrument HAW
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Screw, Fixation, Bone HWC
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Cerclage, Fixation JDQ
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Nail, Fixation, Bone JDS
    Guide, Surgical, Instrument FZX
    Orthopedic Stereotaxic Instrument OLO
    Probe, Radiofrequency Lesion GXI
    Bit, Drill HTW
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Accessories, Arthroscopic NBH

    Proprietary Names

    TIBIAXYS SYSTEM Smith & Nephew, Inc. Newdeal Panta XL Newdeal Compression Plates Hallu Lock plate system Stabilization Screw

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device