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

    4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

    K Number: K102458 · Decision Jun 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    17
    Review Days
    290

    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
    4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
    K Number
    K102458
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Solco Biomedical Co., Ltd.
    Date Received
    August 27, 2010
    Decision Date
    June 13, 2011
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

    Similar 510(k) Clearances

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

    Reliance Spinal Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CastleLoc Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FixxSure® X-Link

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Spinal fixation system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANAX™ 5.5 Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HC Spinal System

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

    Other Clearances by Solco Biomedical Co., Ltd.

    K Number Device Name
    K231655 4CIS® Chiron Spinal Fixation System
    K203233 4CIS Chiron Spinal Fixation System
    K192044 4CIS Marlin PEEK ACIF Cage
    K190563 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
    K190471 4CIS® Chiron Spinal Fixation System
    K182489 4CIS® Pinehurst Anterior Cervical Plate system
    K162402 4CIS® Marlin ACIF Cage System
    K121615 4CIS VANE SPINE SYSTEM
    K101818 4CIS VANE SPINE SYSTEM
    K092162 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
    Search all 17 clearances from Solco Biomedical Co., Ltd. →