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

    Sonoma Fifth Metatarsal Repair System

    K Number: K161371 · Decision Feb 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    9
    Review Days
    283

    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
    Sonoma Fifth Metatarsal Repair System
    K Number
    K161371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sonoma Orthopedic Products, Inc.
    Date Received
    May 17, 2016
    Decision Date
    February 24, 2017
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

    Similar 510(k) Clearances

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

    AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Precice™ Max System and Precice™ Ankle Salvage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Fule Metallic Lockable Intramedullary Nail Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HERA Interlocking Intramedullary Nailing System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FITBONE® TRANSPORT AND LENGTHENING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA

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

    Other Clearances by Sonoma Orthopedic Products, Inc.

    K Number Device Name
    K142945 Sonoma Fibula Repair System
    K111550 SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)
    K100112 SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)
    K092110 WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
    K090304 WAVEON WRX BONE FIXATION SYSTEM
    K081832 ENSPLINTCMX CLAVICLE PIN
    K080778 ENSPLINT TM BONE SCREW
    K071809 ENSPLINTRX BONE FIXATION SYSTEM