BEUDAMED
    FDA Registration Active 🇫🇷 France

    AMPLITUDE

    Reg #: 3009590742 · FEI: 3009590742 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    28
    Establishment Types
    3
    Classifications
    24

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    Registration Details

    Registration Name
    AMPLITUDE
    Registration Number
    3009590742
    FEI Number
    3009590742
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11 Cours Jacques Offenbach, Zone Mozart 2
    City
    Valence Drome
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K230078

    Owner / Operator

    Firm Name
    AMPLITUDE
    Operator Number
    10054515
    Address
    11 Cours Jacques Offenbach, ZA Mozart 2
    City
    Valence
    State
    Drome
    Postal Code
    26000
    Country
    FR
    Correspondent
    Mireille A Lemery

    US Agent

    Business Name
    FDAbasics
    Contact Name
    Emily Matorin
    Address
    1 Prospect Park W Apt 4d
    City
    Brooklyn
    State
    NY
    ZIP
    11215
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Punch, Surgical LRY
    Driver, Prosthesis HWR
    Impactor HWA
    Template HWT
    Forceps HTD
    Orthopedic Manual Surgical Instrument LXH
    Probe HXB
    Caliper KTZ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Wrench HXC
    Chisel, Surgical, Manual FZO
    Bit, Drill HTW
    Guide, Surgical, Instrument FZX
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Retractor GAD
    Extractor HWB
    Clamp, Surgical, General & Plastic Surgery GDJ
    Instrument, Cutting, Orthopedic HTZ
    Hammer, Surgical FZY
    Table, Surgical With Orthopedic Accessories, Manual JEB
    Reamer HTO
    Osteotome HWM
    Rasp, Surgical, General & Plastic Surgery GAC
    Screwdriver HXX

    Proprietary Names

    Punch Driver Impactor Template for Clinical Use Forceps Surgical instruments Probe TOWNLEY Caliper 115 mm Wrench Chisel Drill bit Guide Surgical instrument Anatomic Total Knee System Retractor Extractor Clamp Cutting instrument Hammer Orthopedic tray for E.T.O.I.L.E Connector for E.T.O.I.L.E Orthopedic table EXTENSION E.T.O.I.L.E Shoe for E.T.O.I.L.E Posterior support block for E.T.O.I.L.E Reamer Osteotome Rasp Screwdriver

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device