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

    CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC

    K Number: K133455 · Decision Mar 27, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    26
    Review Days
    135

    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
    CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
    K Number
    K133455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pioneer Surgical Technology, Inc.
    Date Received
    November 12, 2013
    Decision Date
    March 27, 2014
    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 Pioneer Surgical Technology, Inc.

    K Number Device Name
    K251436 Resolve Anterior Cervical Plate System
    K222493 CODA™ Anterior Cervical Plate System
    K211408 CervAlign® Anterior Cervical Plate System
    K192396 Streamline MIS Spinal Fixation System
    K140696 STREAMLINE TL SPINAL FIXATION SYSTEM
    K133623 C-PLUS
    K132050 NB3D BONE VOID FILLER
    K133785 TRITIUM STERNAL CABLE PLATE SYSTEM
    K131724 PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
    K131100 STREAMLINE TL SPINAL SYSTEM
    Search all 26 clearances from Pioneer Surgical Technology, Inc. →