BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Xpert PFP

    K Number: K261038 · Decision May 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    32
    Review Days
    60

    Basic Information

    Device Name
    Xpert PFP
    K Number
    K261038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Newclip Technics
    Date Received
    March 30, 2026
    Decision Date
    May 29, 2026
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

    Similar 510(k) Clearances

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

    I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Exalta Proximal Tibia Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APTUS Clavicle System 2.8

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Pectus Blu System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Avanti Distal Elbow ORIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OrthoPediatrics® Locking Cannulated Blade Plate System

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

    Other Clearances by Newclip Technics

    K Number Device Name
    K253906 Xpert Hand
    K250767 Newclip Patient-matched instrumentation non sterile PSI
    K250155 Xpert Knee
    K243912 Newclip Patient-matched instrumentation non sterile PSI
    K240415 Newclip Patient-matched instrumentation non sterile PSI
    K241539 Activmotion S
    K221615 Newclip Patient-matched instrumentation non sterile PSI
    K221395 Footmotion Plating System
    K202803 Activmotion S DTO
    K213214 Xpert Wrist
    Search all 32 clearances from Newclip Technics →