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

    BONE-LOK HP WASHER

    K Number: K040250 · Decision Mar 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    272
    Registration Numbers
    272
    Same Product Code
    92
    Applicant Total
    11
    Review Days
    50

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    Basic Information

    Device Name
    BONE-LOK HP WASHER
    K Number
    K040250
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Triage Medical, Inc.
    Date Received
    February 2, 2004
    Decision Date
    March 23, 2004
    Product Code
    HTN
    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
    HTN Washer, Bolt Nut

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    Other Clearances by Triage Medical, Inc.

    K Number Device Name
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    K052043 3.8MM CS FACET COMPRESSION DEVICE
    K051949 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
    K043351 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N
    K042244 BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
    K014304 BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
    K014243 BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050
    K012817 HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
    K012818 HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
    K012280 TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
    Search all 11 clearances from Triage Medical, Inc. →