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

    REPROCESSED PINS

    K Number: K100707 · Decision Jun 25, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    59
    Review Days
    105

    Basic Information

    Device Name
    REPROCESSED PINS
    K Number
    K100707
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    STERILMED, INC.
    Date Received
    March 12, 2010
    Decision Date
    June 25, 2010
    Product Code
    NDM
    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
    NDM Pin, Fixation, Threaded, Metallic

    Other Clearances by STERILMED, INC.

    K Number Device Name
    K161700 SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
    K153006 Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
    K152090 Reprocessed Steerable Introducer
    K152134 Reprocessed Vessel Sealer
    K150357 Reprocessed Electrophysiology Diagnostic Catheters
    K143562 Reprocessed Cordless Ultrasonic Dissection Device
    K143260 Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
    K132566 REPROCESSED HARMONIC SHEAR
    K133414 REPROCESSED CLOSURE SYSTEM
    K123096 REPROCESSED VESSEL SEALER
    Search all 59 clearances from STERILMED, INC. →