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

    SPACE 360 DELIVERY SYSTEM

    K Number: K070351 · Decision Jun 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    107
    Applicant Total
    5
    Review Days
    143

    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
    SPACE 360 DELIVERY SYSTEM
    K Number
    K070351
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dfine, Inc.
    Date Received
    February 6, 2007
    Decision Date
    June 29, 2007
    Product Code
    NDN
    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
    NDN Cement, Bone, Vertebroplasty

    Similar 510(k) Clearances

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

    XeliteMed SuperM-Fix Spinal Bone Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VCFix Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XeliteMed VertehighFix High Viscosity Spinal Bone Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Balloon Inflation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    V-STRUT® Vertebral Implant

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

    Other Clearances by Dfine, Inc.

    K Number Device Name
    K091310 ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682
    K090986 STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)
    K072496 MODIFICATION TO SPACE CPSXL BONE CEMENT
    K061531 SPACE CPSXL BONE CEMENT