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

    NEXFLEX TOTAL HIP SYSTEM

    K Number: K033580 · Decision Aug 5, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    6
    Review Days
    266

    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
    NEXFLEX TOTAL HIP SYSTEM
    K Number
    K033580
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nexmed, Inc.
    Date Received
    November 13, 2003
    Decision Date
    August 5, 2004
    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 Nexmed, Inc.

    K Number Device Name
    K991882 NEXFLEX TOTAL KNEE SYSTEM
    K955171 NEXLOCK FEMORAL STEM
    K955170 NEXFLEX FEMORAL STEM, STANDARD DESIGN
    K952629 NEXFLEX TOTAL HIP SYSTEM
    K951656 NEXMED CANCELLOUS BONE SCREWS