BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ProAdjuster

    Reg #: 2531782 · FEI: 3002546832 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SIGMA INSTRUMENTS, INC.
    Registration Number
    2531782
    FEI Number
    3002546832
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    506 THOMSON PARK DR.
    City
    CRANBERRY TOWNSHIP
    State
    PA
    ZIP
    16066
    Country
    US

    Regulatory Submissions

    510(k) Number
    K962239

    Owner / Operator

    Firm Name
    SIGMA INSTRUMENTS, I
    Operator Number
    9039899
    Address
    506 THOMSON PARK DR., --
    City
    Cranberry Twp
    State
    PA
    Postal Code
    16066
    Country
    US
    Correspondent
    JOHN B CRUNICK

    Products

    Device Name Product Code
    Manipulator, Plunger-Like Joint LXM

    Proprietary Names

    ProAdjuster Ultralign Yamasaki System SA201

    Establishment Types

    Manufacture Medical Device