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

    ASCENSION ATLAS HUMERAL PLATING SYSTEM

    K Number: K110700 · Decision Dec 6, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    505
    Registration Numbers
    505
    Same Product Code
    1254
    Applicant Total
    20
    Review Days
    267

    Basic Information

    Device Name
    ASCENSION ATLAS HUMERAL PLATING SYSTEM
    K Number
    K110700
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ASCENSION ORTHOPEDICS, INC.
    Date Received
    March 14, 2011
    Decision Date
    December 6, 2011
    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.

    TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Genostis Osteosynthesis System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Equinoxe® Scapula Fracture System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LORRAINE 2.5/3.5mm Distal Humerus System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Montblanc Plate System

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

    Other Clearances by ASCENSION ORTHOPEDICS, INC.

    K Number Device Name
    K121826 INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
    K102549 THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
    K100448 ASCENSION MODULAR TOTAL SHOULDER SYSTEM
    K100502 ASCENSION TOTAL PLATE SYSTEM
    K100925 ASCENSION ANKLE FUSION NAIL SYSTEM
    K100176 ASCENSION ANKLE FUSION PLATE SYSTEM
    K092047 ASCENSION METAL GREAT TOE SYSTEM
    K092440 ASCENSION CANNULATED SCREW SYSTEM
    K082231 ASCENSION SILICONE PIP
    K080997 ASCENSION PYROCARBON LUNATE
    Search all 20 clearances from ASCENSION ORTHOPEDICS, INC. →