BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP

    K Number: K112019 · Decision Oct 12, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    98
    Applicant Total
    33
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
    K Number
    K112019
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3390
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Corentec Co., Ltd.
    Date Received
    July 14, 2011
    Decision Date
    October 12, 2011
    Product Code
    KWY
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KWY), ordered by most recent decision date.

    b-ONE® Bipolar Head

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Maxx Libertas Bipolar Hip Head (Bipolar Hip)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CORAIL Cemented Femoral Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SpaceFlex Acetabular Cup

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vario-Cup System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COPAL exchange G hip spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Corentec Co., Ltd.

    K Number Device Name
    K250889 EXULT Knee Replacement System
    K242401 EXULT Knee Replacement System
    K242046 EXULT Knee Replacement System
    K223828 BENCOX Delta Option Heads
    K223223 BENCOX Mirabo Z Cup Cortinium
    K222278 LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation
    K210614 BENCOX Mirabo Z Cup Cortinium
    K220468 BENCOX Mirabo Cup System
    K212034 LOSPA TKR System
    K211866 Bencox THR System
    Search all 33 clearances from Corentec Co., Ltd. →