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510(k) Data Aggregation

    K Number
    K132893
    Device Name
    EDGE ORTHOPAEDICS BITE COMPRESSION SCREW
    Manufacturer
    ICON ORTHOPAEDIC CONCEPTS DBA EDGE ORTHOPAEDICS
    Date Cleared
    2013-11-20

    (65 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICON ORTHOPAEDIC CONCEPTS DBA EDGE ORTHOPAEDICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EDGE Orthopaedics' BITE™ Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. BITE Compression Screws are intended for single use only. BITE Compression Screws are intended for use over a guide pin or wire. EDGE Orthopaedics' washers may be used with the headed screws in cases where the patient has poor bone quality. Examples of small and long bone indications for which BITE Compression screws are used: - Minimally invasive fracture/joint reconstructions - Multiple-fragment joint fractures - Simple epiphyseal fractures - Fractures of the head of the humerus - Fractures of the head of the tibia - Cooper fractures of the tibia - Fractures of the radius - Fractures of the wrist, ankle, elbow and shoulder - Scaphoid fractures and other fractures of the hand - Metatarsal fractures and other fracture of the foot - Ligament fixation of the proximal humerus - Ligament avulsion injuries (Apohysis) - Fractures of small joint bones - Malleolar fractures - Navicular fractures - Fractures of the calcaneus and talus - Arthrodesis of the ankle joint - Avulsion fracture and metatarsal V - Fractures of the tarsal region - Osteotomies BITE Compression Screws are not intended for use in the spine.
    Device Description
    The EDGE Orthopaedics BITE™ Compression Screws include sterile titanium self- drilling and self- tapping screws. The corresponding instrumentation (depth gauges, forceps, screwdrivers, retractors, and tenaculums) to facilitate insertion is found in EDGE's RIVAL™ Instrument Tray. The cannulated compression screws are offered in a variety of diameters and lengths designed for the temporary fixation, correction or stabilization of bones. The unique low profile head design, cutting characteristics and vast screw options of the BITE Compression Screws provides extensive versatility in one comprehensive system.
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