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

    CONSENSUS UNIPOLAR HEAD, COCR

    K Number: K030205 · Decision Apr 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    106
    Applicant Total
    12
    Review Days
    70

    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
    CONSENSUS UNIPOLAR HEAD, COCR
    K Number
    K030205
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hayes Medical, Inc.
    Date Received
    January 21, 2003
    Decision Date
    April 1, 2003
    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 Hayes Medical, Inc.

    K Number Device Name
    K070061 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
    K062383 UNISYN HA PLASMA MODULAR HIP
    K060635 CONSENSUS ACETABULAR SHELL SYSTEM
    K030151 CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
    K021466 CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
    K020153 CONSENSUS ACETABLAR SHELL, TI COATED
    K003649 TRITON HIP SYSTEM
    K001456 CONSENSUS KNEE SYSTEM
    K983004 CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI
    K964395 PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT
    Search all 12 clearances from Hayes Medical, Inc. →