BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    implantcast GmbH

    Reg #: 3012523063 · FEI: 3012523063 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    25
    Establishment Types
    3
    Classifications
    24

    Registration Details

    Registration Name
    implantcast GmbH
    Registration Number
    3012523063
    FEI Number
    3012523063
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lueneburger Schanze 26
    City
    Buxtehude Lower Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K191569

    Owner / Operator

    Firm Name
    implantcast GmbH
    Operator Number
    10054139
    Address
    Lueneburger Schanze 26
    City
    Buxtehude
    State
    Lower Saxony
    Postal Code
    21614
    Country
    DE
    Correspondent
    Juliane Hoeppner

    US Agent

    Business Name
    IMPLANTCAST AMERICA, LLC
    Contact Name
    Andrew Hewes
    Address
    13465 Midway Rd, Ste 310
    City
    Dallas
    State
    TX
    ZIP
    75244
    Country
    US
    Email
    [email protected]
    Phone
    512 7797282

    Products

    Device Name Product Code
    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
    Reamer HTO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Wrench HXC
    Awl HWJ
    Forceps HTD
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Shoulder Prosthesis, Reverse Configuration PHX
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Impactor HWA
    Gauge, Depth HTJ
    Template HWT
    Tray, Surgical, Instrument FSM
    Broach HTQ
    Extractor HWB
    Screwdriver HXX
    Hammer, Surgical FZY
    Orthopedic Manual Surgical Instrument LXH
    Bit, Drill HTW

    Proprietary Names

    ic-Bipolar Head System implaFit® trial neck K12/14 std. stem implaFit® Hip Stem implaFit® broach MUTARS socket wrench MUTARS engineers wrench SW 24 MUTARS torque wrench M8 M10 implantcast Packaging System Update Actinia® hip stems EcoFit® Hip System AGILON® XO Shoulder System resection guide implaFit® short stem broach implaFit® short stems ACS® LD FB Knee System AGILON® XO Shoulder Replacement System Ecofit Hip System ACS® LD Uni FB Knee System EcoFit® short stem cementless cpTi MUTARS® femoral stem cemented 160 mm and 200 mm EPORE® XO cup system Drilling pin MUTARS Proximal Femur Replacement System BethaLoc® stem cementless HA MUTARS femoral stem cemented

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198