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

    SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)

    K Number: K800898 · Decision May 2, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    52
    Applicant Total
    31
    Review Days
    14

    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
    SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)
    K Number
    K800898
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    April 18, 1980
    Decision Date
    May 2, 1980
    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 Dow Corning Corp. Healthcare Industries Materials

    K Number Device Name
    K853186 SILASTIC INFLATABLE BONE PLUG H.P.
    K844637 WHITESIDE ACRYLIC CEMENT SPACER SLEEVE
    K850255 DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET
    K843995 TF-II HIP PROSTHESIS
    K842559 WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
    K840357 SSA HIP PROSTHESIS
    K831479 METAL-BACKED ACETABULAR CUP
    K812864 SILASTIC VOICE PROSTHESIS
    K812053 SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
    K811679 SILASTIC TENDON PASSER H.P.
    Search all 31 clearances from Dow Corning Corp. Healthcare Industries Materials →