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

    THEKEN SPINE VU EPOD AND VU LPOD SYSTEM

    K Number: K082712 · Decision Jan 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    23
    Review Days
    108

    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
    THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
    K Number
    K082712
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Theken Spine, LLC
    Date Received
    September 16, 2008
    Decision Date
    January 2, 2009
    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.

    Fule Interbody Fusion Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Exceed® Biplanar Expandable Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BMD Titanium Spinal Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ventana® P/T Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VersaLift Expandable System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system

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

    Other Clearances by Theken Spine, LLC

    K Number Device Name
    K121482 INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
    K121211 VU APOD INTERVERTEBRAL BODY FUSION DEVICE
    K120829 STAINLESS STEEL SPINAL SYSTEM
    K120047 CORAL SPINAL SYSTEM
    K111675 VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
    K103228 PARAMOUNT R IBF DEVICE
    K102323 CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
    K101310 VU APOD INTERVERTEBRAL BODY FUSION DEVICE
    K100970 STAINLESS STEEL SPINAL SYSTEM
    K091266 THEKEN CORAL SPINAL SYSTEM
    Search all 23 clearances from Theken Spine, LLC →