BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    NEST Interbody System

    K Number: K180230 · Decision Jan 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    6
    Review Days
    364

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    Basic Information

    Device Name
    NEST Interbody System
    K Number
    K180230
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paonan Biotech Co., Ltd.
    Date Received
    January 26, 2018
    Decision Date
    January 25, 2019
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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    Other Clearances by Paonan Biotech Co., Ltd.

    K Number Device Name
    K220261 NEST-C Interbody System
    K182285 PK High Tibial Osteotomy Correction System
    K180228 II-Type Intervertebral Spacer
    K180226 TREND II Spinal Fixation System- STEP Series
    K161225 Paonan Armstrong Posterior Spinal Fixation System