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

    WUJIN #3 TIBIAL NAIL

    K Number: K002325 · Decision Oct 30, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    52
    Applicant Total
    9
    Review Days
    90

    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
    WUJIN #3 TIBIAL NAIL
    K Number
    K002325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biologically Oriented Prostheses
    Date Received
    August 1, 2000
    Decision Date
    October 30, 2000
    Product Code
    JDS
    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
    JDS Nail, Fixation, Bone

    Similar 510(k) Clearances

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

    TRIGEN Stable Lock Nut & Washer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIGEN INTERTAN 10S Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NET BRAND Osteosynthesis Nailing System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIGEN META-NAIL Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm

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

    Other Clearances by Biologically Oriented Prostheses

    K Number Device Name
    K992144 BIOPRO RIMMED ACETABULAR COMPOMENT
    K964472 RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
    K962769 HORIZON HIP SYSTEM
    K955916 TOWNLEY TOTAL ELBOW SYSTEM
    K954768 BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
    K952731 TOWNLEY ALL POLY ACETABULAR CUP
    K953045 BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
    K951356 VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED