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

    Battalion Universal Spacer System

    K Number: K160958 · Decision Sep 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    156

    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
    Battalion Universal Spacer System
    K Number
    K160958
    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
    Date Received
    April 5, 2016
    Decision Date
    September 8, 2016
    Product Code
    PHM
    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
    PHM Intervertebral Fusion Device With Bone Graft, Thoracic

    Similar 510(k) Clearances

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

    ATEC Universal Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NuVasive CoRoent Thoracolumbar Implants

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

    Other Clearances by Alphatec Spine

    K Number Device Name
    K251575 IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System
    K241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer
    K240951 Invictus Robotic Navigation Instruments
    K222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System
    K191185 Solanas® Posterior OCT Fixation System