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

    MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

    K Number: K211313 · Decision May 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    45
    Review Days
    25

    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
    MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
    K Number
    K211313
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (USA) Products, LLC
    Date Received
    April 30, 2021
    Decision Date
    May 25, 2021
    Product Code
    KTT
    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

    Similar 510(k) Clearances

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

    MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNEX® External Fixation Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QuikFix External Fixator: Knee-Spanning Pack

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Excelsior System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hoffmann LRF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Monkey Rings External Ring Fixation System

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

    Other Clearances by Synthes (USA) Products, LLC

    K Number Device Name
    K254087 MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System
    K212943 SyntheCel Dura Repair
    K210408 DePuy Synthes Variable Angle Locking Patella Plating System
    K210205 DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
    K201346 DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
    K192702 DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
    K201944 DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
    K201578 DePuy Synthes Variable Angle Locking Patella Plating System
    K201336 DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
    K191463 DePuy Synthes Hammertoe Continuous Compression Implant
    Search all 45 clearances from Synthes (USA) Products, LLC →