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

    DRG ORTHOHEX SS BONE SCREW

    K Number: K013786 · Decision Dec 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    13
    Review Days
    33

    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
    DRG ORTHOHEX SS BONE SCREW
    K Number
    K013786
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Doctor'S Research Group, Inc.
    Date Received
    November 14, 2001
    Decision Date
    December 17, 2001
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

    Similar 510(k) Clearances

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

    VEOFIX Snap Off Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoLink® & CoLag® Non-Sterile Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TriMed Compression Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex Beaming System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSSIOfiber® Threaded Trimmable Fixation Nail

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TITAN Nail; APTUS K-Wire System

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

    Other Clearances by Doctor'S Research Group, Inc.

    K Number Device Name
    K051487 DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
    K041018 DRG SOFTRELEASE
    K012535 DRG DISPOSABLE VAGINAL SPECULUM
    K012003 DRG REACTION CHAMBER/SAFETY TIP
    K011736 DRG QUICKMIX
    K002047 DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2
    K991714 DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
    K990212 LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
    K990920 DRG TITANIUM BONE PLATE
    K981881 DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING
    Search all 13 clearances from Doctor'S Research Group, Inc. →