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

    GPS Cervical Spacers

    K Number: K210890 · Decision Apr 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    7
    Review Days
    29

    Basic Information

    Device Name
    GPS Cervical Spacers
    K Number
    K210890
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    G Surgical, LLC
    Date Received
    March 25, 2021
    Decision Date
    April 23, 2021
    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 G Surgical, LLC

    K Number Device Name
    K240737 G Surgical Marksman MIS System
    K230063 G Surgical Marksman Spinal Deformity System
    K193219 G Surgical Marksman System
    K171834 G Surgical OCT Spinal System
    K161516 G Surgical Marksman MIS System
    K142456 GPS Spacers