BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    CyclaPlex Correction System

    Reg #: 3016250463 · FEI: 3016250463 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    AlphMet Ltd
    Registration Number
    3016250463
    FEI Number
    3016250463
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 HaDolev st, BarLev High Tech Park
    City
    Misgav Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K183094

    Owner / Operator

    Firm Name
    AlphaMet Ltd.
    Operator Number
    10062071
    Address
    1 HaZmicha St., Open Valey office
    City
    Yokneam
    State
    IL-NOTA
    Postal Code
    2069205
    Country
    IL
    Correspondent
    Rafi Herzog

    US Agent

    Business Name
    Paladin Medical
    Contact Name
    Elaine Duncan
    Address
    415 Valley View Trail
    City
    Houlton
    State
    WI
    ZIP
    54082
    Country
    US
    Email
    [email protected]
    Phone
    715 5496035

    Products

    Device Name Product Code
    Washer, Bolt Nut HTN

    Proprietary Names

    CyclaPlex Correction System AlphaMet ISD

    Establishment Types

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