BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ULTIMA UNIPOLAR MODULAR HEAD

    K Number: K940190 · Decision Sep 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    106
    Applicant Total
    22
    Review Days
    259

    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
    ULTIMA UNIPOLAR MODULAR HEAD
    K Number
    K940190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Orthopaedics, Inc.
    Date Received
    January 13, 1994
    Decision Date
    September 29, 1994
    Product Code
    KWL
    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
    KWL Prosthesis, Hip, Hemi-, Femoral, Metal

    Similar 510(k) Clearances

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

    Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OsteoRemedies Hip Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InterSpace GV Hip Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COPAL® exchange G hip spacer; COPAL® G+V

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UHR Bipolar Implants, Restoration GAP II Implants

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

    Other Clearances by Johnson & Johnson Orthopaedics, Inc.

    K Number Device Name
    K931466 PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI
    K935452 P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
    K933275 P.F.C. CERAMIC HIP HEAD
    K932595 ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR
    K931655 P.F.C. BIPOLAR HIP SYSTEM
    K933867 UNIVERSAL INSET PATELLA
    K935262 P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA
    K931189 P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET
    K931054 TRICK MODULAR KNEE TIBIAL TRAY-POROUS
    K924340 P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT
    Search all 22 clearances from Johnson & Johnson Orthopaedics, Inc. →