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

    COMET Lumbar Interbody Fusion Cage

    K Number: K191353 · Decision Apr 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    5
    Review Days
    329

    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
    COMET Lumbar Interbody Fusion Cage
    K Number
    K191353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baui Biotech Co., Ltd.
    Date Received
    May 21, 2019
    Decision Date
    April 14, 2020
    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

    Similar 510(k) Clearances

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

    Fule Interbody Fusion Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Exceed® Biplanar Expandable Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BMD Titanium Spinal Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ventana® P/T Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VersaLift Expandable System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system

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

    Other Clearances by Baui Biotech Co., Ltd.

    K Number Device Name
    K242899 NOVA Minimally Invasive System
    K191494 Facilis™ Spinal System
    K182416 NOVA Minimally Invasive System
    K161231 Facilis™ Spinal System