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

    RECONSTRUCTION PLATE SYSTEM

    K Number: K924085 · Decision Dec 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    23
    Review Days
    126

    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
    RECONSTRUCTION PLATE SYSTEM
    K Number
    K924085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Sofamor Danek Mfg., Inc.
    Date Received
    August 13, 1992
    Decision Date
    December 17, 1992
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

    Similar 510(k) Clearances

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

    I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Exalta Proximal Tibia Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APTUS Clavicle System 2.8

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Pectus Blu System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Xpert PFP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Avanti Distal Elbow ORIF System

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

    Other Clearances by Sofamor Danek Mfg., Inc.

    K Number Device Name
    K936294 SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
    K930191 DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY
    K932029 TSRH SPINAL SCREWS
    K922486 DANEK TISSUE CUTTING AND REMOVAL SYSTEM
    K930807 SENTRY ANTERIOR SPINAL SYSTEM
    K930710 SENTRY POSTERIOR SPINAL SYSTEM
    K923242 CROSSLINK AXIAL AND OFFSET PLATES
    K922543 Z-PLATE ANTERIOR FIXATION SYSTEM
    K922672 AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
    K925811 TSRH CENTRAL POST HOOKS
    Search all 23 clearances from Sofamor Danek Mfg., Inc. →