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

    APEX HCLA ACETABULAR CUP LINERS

    K Number: K062489 · Decision Aug 15, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    7
    Review Days
    355

    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
    APEX HCLA ACETABULAR CUP LINERS
    K Number
    K062489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omnilife Science
    Date Received
    August 25, 2006
    Decision Date
    August 15, 2007
    Product Code
    LPH
    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
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    Similar 510(k) Clearances

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

    iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Taperloc® Complete Hip Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G7® Revision Acetabular System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mpact 3D Metal Implants Extension – DMLS Technology

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Velora Acetabular System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TaperSet™ Hip System

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

    Other Clearances by Omnilife Science

    K Number Device Name
    K201611 Apex Knee System
    K172467 OMNI ARC Anteverted Neck Hip Stem
    K171156 OMNI Anseris Hip Stem
    K163332 Apex Revision Knee System
    K153437 Apex Revision Knee System
    K133381 OMNI ARC MONOBLOCK HIP STEM