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

    Geo Staple System

    K Number: K182212 · Decision Jan 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    5
    Review Days
    149

    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
    Geo Staple System
    K Number
    K182212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gramercy Extremity Orthopedics, LLC
    Date Received
    August 15, 2018
    Decision Date
    January 11, 2019
    Product Code
    JDR
    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
    JDR Staple, Fixation, Bone

    Similar 510(k) Clearances

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

    Linkt Compression Staple System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Medline UNITE® REFLEX® Hybrid Nitinol Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex DynaNite Nitinol Staples

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TMC Compression Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TMC Compression Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COGNiTiON™ Staple System

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

    Other Clearances by Gramercy Extremity Orthopedics, LLC

    K Number Device Name
    K212334 GEO Extremity and Ankle Plating System
    K210534 GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
    K202817 GEO Bone Screw System
    K200108 GEO 1st MTP Joint Arthrodesis Plating System