BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Prase MIS Spinal System

    K Number: K182059 · Decision Oct 4, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    14
    Review Days
    65

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    Basic Information

    Device Name
    Prase MIS Spinal System
    K Number
    K182059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gbs Commonwealth Co., Ltd.
    Date Received
    July 31, 2018
    Decision Date
    October 4, 2018
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by Gbs Commonwealth Co., Ltd.

    K Number Device Name
    K233839 Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system
    K233084 Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
    K232292 Peridot-EX Expandable Intervertebral Body Fusion System
    K232822 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
    K230708 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
    K213755 Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
    K213980 Peridot Spinal Interbody System
    K211205 Prase-C Anterior Cervical Plate System
    K202872 Prase PEEK Anterior Cervical Interbody Spacer
    K202878 Prase-AP Anterior Cervical Plate System
    Search all 14 clearances from Gbs Commonwealth Co., Ltd. →