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

    AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM

    K Number: K962002 · Decision Aug 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    58
    Applicant Total
    186
    Review Days
    78

    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
    AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
    K Number
    K962002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exactech, Inc.
    Date Received
    May 22, 1996
    Decision Date
    August 8, 1996
    Product Code
    JDG
    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
    JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

    Similar 510(k) Clearances

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

    Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Distal Centralizers

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THE TAPER-FIT TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEXLOCK FEMORAL STEM

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

    Other Clearances by Exactech, Inc.

    K Number Device Name
    K260583 Equinoxe® Shoulder System
    K250713 Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
    K243448 Equinoxe® Shoulder System
    K243275 Equinoxe® Scapula Fracture System
    K243839 Alteon® HA Femoral Stems
    K240393 Exactech® TRULIANT® Knee System
    K233482 Equinoxe® Central Screw Baseplate System
    K230717 Exactech® Vantage® Total Ankle System
    K223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
    K223833 Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
    Search all 186 clearances from Exactech, Inc. →