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

    ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL

    K Number: K101588 · Decision Jan 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    161
    Applicant Total
    6
    Review Days
    214

    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
    ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
    K Number
    K101588
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apollo Spine, Inc.
    Date Received
    June 7, 2010
    Decision Date
    January 7, 2011
    Product Code
    OVE
    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
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

    Similar 510(k) Clearances

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

    CONDUIT™ ZERO-P™ VA Secured Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NeckTune™ 3D SA Cervical Cage

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SABER-C System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SAGI Cervical Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Uni-C Cervical Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    E3D™-C Interbody System

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

    Other Clearances by Apollo Spine, Inc.

    K Number Device Name
    K120340 VENUS FACET SCREW SYSTEM
    K102636 ZENITH PEDICLE SYSTEM
    K102121 ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR
    K090751 COMET ANTERIOR CERVICAL PLATE SYSTEM
    K082504 APOLLO ANTERIOR CERVICAL PLATE SYSTEM