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

    JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF

    K Number: K123485 · Decision Mar 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    9
    Review Days
    125

    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
    JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
    K Number
    K123485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Sports Medicine
    Date Received
    November 13, 2012
    Decision Date
    March 18, 2013
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

    Similar 510(k) Clearances

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

    Dione PEEK Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Y-Knotless™ Flex Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Anchor with Fiber Wire and Disposable Inserter

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArthroTAK Tendon Anchor Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex FiberTak Suture Anchor

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

    Other Clearances by Biomet Sports Medicine

    K Number Device Name
    K140908 JUGGERKNOT MINI SOFT ANCHOR
    K122437 NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
    K110879 BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
    K111564 MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
    K110039 BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
    K103145 HAMMERLOC TM TIBIAL FIXATION DEVICE
    K101063 SLEEVE WITH ZIPLOOP FIXATION DEVICES
    K083070 TOGGLELOC SYSTEM