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

    DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional

    K Number: K172975 · Decision Jun 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    5
    Review Days
    267

    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
    DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
    K Number
    K172975
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
    Date Received
    September 27, 2017
    Decision Date
    June 21, 2018
    Product Code
    JDQ
    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
    JDQ Cerclage, Fixation

    Similar 510(k) Clearances

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

    Stitch Cerclage – Suture Tapes

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mbrace Cable

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCORD Cable System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VariTrax Sternal CircumFixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex Radiopaque FiberTape Cerclage sutures

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

    Other Clearances by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

    K Number Device Name
    K192745 DePuy Synthes Trauma Screws
    K181933 DePuy Synthes Sterilization Container System
    K180310 DePuy Synthes Trauma Orthopedic Plates and Screws
    K160553 DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S