BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRIAL DISTAL ULNAR HEAD HEAD SIZE 3 17-1077

    Reg #: 1828288 · FEI: 1828288 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORCHID UNIQUE
    Registration Number
    1828288
    FEI Number
    1828288
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6688 Dixie Hwy
    City
    Bridgeport
    State
    MI
    ZIP
    48722
    Country
    US

    Regulatory Submissions

    510(k) Number
    K010786

    Owner / Operator

    Firm Name
    Unique Instruments Inc.
    Operator Number
    10042005
    Address
    6688 Dixie Hwy
    City
    Bridgeport
    State
    MI
    Postal Code
    48722
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Wrist, Hemi-, Ulnar KXE

    Proprietary Names

    TRIAL DISTAL ULNAR HEAD HEAD SIZE 3 17-1077 TRIAL DISTAL ULNAR HEAD STEM SIZE 2 17-1079 TRIAL DISTAL ULNAR HEAD HEAD SIZE 2 17-1076 TRIAL DISTAL ULNAR HEAD STEM SIZE 3 17-1080 ULNAR BROACH , SIZE 1 17-1106 COLLAR SPACER 20mm DISTAL ULNAR HEAD 17-1096 TRIAL DISTAL ULNAR HEAD SIZE 1 17-1102 TRIAL DISTAL ULNAR HEAD STEM SIZE 1 17-1104 ULNAR BROACH, SIZE 2 17-1082 ULNAR BROACH, SIZE 4 17-1084 TRIAL DISTAL ULNAR HEAD HEAD SIZE 4 17-1078 TRIAL DISTAL ULNAR HEAD STEM SIZE 4 17-1081 IMPACTOR 17-1088 RESECTION GUIDE DISTAL ULNAR HEAD 17-1091 ULNAR BROACH, SIZE 3 17-1083

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)