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

    MODIFICATION TO: CAPSTONE SPINAL SYSTEM

    K Number: K082732 · Decision Oct 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    422
    Registration Numbers
    422
    Same Product Code
    869
    Applicant Total
    83
    Review Days
    28

    Basic Information

    Device Name
    MODIFICATION TO: CAPSTONE SPINAL SYSTEM
    K Number
    K082732
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Date Received
    September 18, 2008
    Decision Date
    October 16, 2008
    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.

    PathLoc Lumbar Interbody Fusion Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    aprevo® posterior/transforaminal lumbar interbody fusion device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Testa TP Pivoting Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    X-PAC® LLIF Expandable Lateral Cage System

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

    Other Clearances by MEDTRONIC SOFAMOR DANEK USA, INC.

    K Number Device Name
    K162212 DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
    K162680 SOVEREIGN® Spinal System
    K162379 CD HORIZON® Spinal System
    K153589 CD HORIZON Spinal System
    K153463 CD HORIZON Spinal System, IPC POWEREASE System
    K152457 CD HORIZON Spinal System
    K150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
    K142648 SPINEDESIGN Spine Surgery Planning (Software Application)
    K141599 DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
    K141632 ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
    Search all 83 clearances from MEDTRONIC SOFAMOR DANEK USA, INC. →