BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Graham Medical Technologies, L.L.C. d.b.a. GraMedica

    Reg #: 3004993707 · FEI: 3004993707 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    28
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Graham Medical Technologies, L.L.C. d.b.a. GraMedica
    Registration Number
    3004993707
    FEI Number
    3004993707
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    236 Mill St
    City
    Rochester
    State
    MI
    ZIP
    48307
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142478

    Owner / Operator

    Firm Name
    GRAMEDICA
    Operator Number
    9069880
    Address
    236 Mill Street, --
    City
    Rochester
    State
    MI
    Postal Code
    48307
    Country
    US

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Pin, Fixation, Smooth HTY
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Scissors, Orthopedic, Surgical HRR

    Proprietary Names

    osteo-WEDGE Drill Guide HyProCure Sizer 06 HyProCure II Trial Sizer 10 HyProCure Sizer 05 osteo-WEDGE Depth Gauge osteo-WEDGE Screw Retainer Sleeve Guide Wire HyProCure II Positioning Sleeve HyProCure Sizer 07 HyProCure Driver HyProCure II Trial Sizer 09 osteo-WEDGE Depth Gauge Sleeve HyProCure II Trial Sizer 08 HyProCure II Trial Sizer 07 HyProCure II Driver HyProCure Sizer 09 osteo-WEDGE Driver HyProCure II Trial Sizer 12 HyProCure II Trial Sizer 06 HyProCure Sizer 08 HyProCure Sizer 10 Opti-Toe osteo-WEDGE Opening Wedge Bone Locking Plate System HYP Sinus Tarsi Decompression Scissors Graham Decompression Scissors Osteo-Wedge II Open Wedgge bone Locking Plate System HyProCure Sinus Tarsi Stent System HyProCure II®

    Establishment Types

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