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

    EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS

    K Number: K092548 · Decision Dec 15, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    25
    Applicant Total
    28
    Review Days
    118

    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
    EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
    K Number
    K092548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3770
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Extremity Medical, LLC
    Date Received
    August 19, 2009
    Decision Date
    December 15, 2009
    Product Code
    KYI
    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
    KYI Prosthesis, Wrist, Carpal Trapezium

    Similar 510(k) Clearances

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

    Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stablyx CMC Arthroplasty Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASCENSION NUGRIP CMC IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARTELON STT SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARTELON CMC SPACER ARTHRO

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

    Other Clearances by Extremity Medical, LLC

    K Number Device Name
    K250536 MetaFore Small Screw System
    K251128 Extremity Medical External Fixation System
    K241563 Extremity Medical External Fixation System
    K212297 Omni Foot and Ankle Plating System
    K211261 Axis Charcot Fixation System
    K201556 Intraosseous Fixation System
    K191525 KinematX Total Wrist Arthroplasty System
    K192592 Axis Plating System
    K181067 AlignX Ankle Fusion System
    K180808 Omni Foot Plating System
    Search all 28 clearances from Extremity Medical, LLC →