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

    ARTHROSURFACE TOEMOTION

    K Number: K132496 · Decision Feb 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    10
    Applicant Total
    26
    Review Days
    201

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    Basic Information

    Device Name
    ARTHROSURFACE TOEMOTION
    K Number
    K132496
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arthrosurface, Inc.
    Date Received
    August 9, 2013
    Decision Date
    February 26, 2014
    Product Code
    LZJ
    Advisory Committee
    Unknown
    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
    LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

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    Other Clearances by Arthrosurface, Inc.

    K Number Device Name
    K203375 OVOMotion Reverse Shoulder Arthroplasty System
    K200718 Arthrosurface WristMotion Total Wrist Arthroplasty System
    K190261 BOSS Toe Fixation System
    K181280 Patello-Femoral Wave (Kahuna) Arthroplasty System
    K173964 OVOMotion Shoulder Arthroplasty System
    K172383 Arthrosurface Bone Screws
    K170440 KISSloc Suture System
    K170350 ToeMATE® Hammertoe Correction System
    K162391 AlignMATE™ Lapidus Arthrodesis System
    K161539 Arthrosurface Bone Screws
    Search all 26 clearances from Arthrosurface, Inc. →