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

    nvc

    K Number: K190380 · Decision Mar 21, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    24
    Review Days
    30

    Basic Information

    Device Name
    nvc
    K Number
    K190380
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nvision Biomedical Technologies, Inc.
    Date Received
    February 19, 2019
    Decision Date
    March 21, 2019
    Product Code
    ODP
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

    Similar 510(k) Clearances

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

    BluEX Cervical Expandable Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSTEOMNI SPINAL CAGES SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORIO-3D Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOD-C

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

    Other Clearances by Nvision Biomedical Technologies, Inc.

    K Number Device Name
    K253718 enHAnce PEEK Bunion System
    K260291 Vortex5 Tailor's Bunion Correction System
    K253423 ToeJack MIS Bunion System
    K252657 Impact PEEK Union Nail System
    K250613 SnapHammer Hammertoe Correction System
    K240250 3D Printed PEEK Interbody System
    K231453 SnapHammer Hammertoe Correction System
    K230853 EARP Nerve Cuff Electrode
    K222015 Integral Titanium Cervical Interbody
    K223226 Trigon™ HA Stand-Alone Wedge Fixation System
    Search all 24 clearances from Nvision Biomedical Technologies, Inc. →