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

    INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC

    K Number: K071922 · Decision Sep 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    7
    Review Days
    68

    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
    INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
    K Number
    K071922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rsb Spine, LLC
    Date Received
    July 12, 2007
    Decision Date
    September 18, 2007
    Product Code
    OVD
    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
    OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

    Similar 510(k) Clearances

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

    Anteralign LS coverplate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MectaLIF 3D Metal Anterior

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCRIPT™ Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ventana™ A Anterior Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DeGen Medical Patient Specific Implant (PSI) System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System

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

    Other Clearances by Rsb Spine, LLC

    K Number Device Name
    K092540 C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
    K092070 INTERPLATE C
    K081194 INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
    K071372 MODIFICATION TO: INTERPLATE VBR SYSTEM
    K070316 INTERPLATE VBR SYSTEM
    K061401 INTERPLATE VBR SYSTEM