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

    IdentiTi ALIF Interbody Systems

    K Number: K232097 · Decision Sep 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    93
    Review Days
    74

    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
    IdentiTi ALIF Interbody Systems
    K Number
    K232097
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alphatec Spine, Inc.
    Date Received
    July 13, 2023
    Decision Date
    September 25, 2023
    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 Alphatec Spine, Inc.

    K Number Device Name
    K253615 Invictus Bands System
    K252597 Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
    K252842 SafeOp 3: Neural Informatix System
    K251965 Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
    K251080 IdentiTi II Cervical Interbody System
    K243461 Calibrate Interbody Systems
    K242364 IdentiTi™ II Interbody System
    K242147 Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
    K241519 Invictus® Small Stature Spinal Fixation System
    K240199 IntraOp Alignment System
    Search all 93 clearances from Alphatec Spine, Inc. →