BEUDAMED
    FDA Registration Active 🇺🇸 United States

    REDAPT DISTAL REAMER 190MM SZ 16

    Reg #: 1828288 · FEI: 1828288 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    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
    K151902

    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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH

    Proprietary Names

    REDAPT DISTAL REAMER 190MM SZ 16 REDAPT DISTAL REAMER 190MM SZ 20 REDAPT DISTAL REAMER 190MM SZ 21 REDAPT DISTAL REAMER 190MM SZ 15 REDAPT DISTAL REAMER 190MM SZ 17 REDAPT DISTAL REAMER 190MM SZ 19 REDAPT DISTAL REAMER 190MM SZ 18

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)