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510(k) Data Aggregation

    K Number
    K153716
    Device Name
    GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
    Manufacturer
    GPC MEDICAL LTD
    Date Cleared
    2016-05-17

    (145 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    GPC MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). The system is indicated for use in adult patients only. All implants are for single use only.
    Device Description
    GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws. The plates and screws are fabricated from Stainless Steel and Titanium. GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, T-Plates, Anatomical Plates and Clavicle Hook Plates. These all are mainly divided into - Large Fragment Plates - . Small Fragment Plates - Mini Fragment Plates ● The number of the holes varies from 2 to 22. The Locking screw implants are in corresponding diameter ranges from 2.4mm, 3.5mm, 5.0mm and 6.5mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 150mm The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm. The non locking screws 3.5mm and 4.5mm were cleared previously in 510k number K092493 These implants are supplied non-sterile, the products have to be sterilized prior to use.
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    K Number
    K092493
    Device Name
    GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM
    Manufacturer
    GPC MEDICAL LTD
    Date Cleared
    2010-03-29

    (227 days)

    Product Code
    HRS, HWC, KTT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    GPC MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GPC BONE PLATES AND BONE SCREWS ARE PROVIDED NON-STERILE. GPC BONE PLATES AND SCREWS ARE INTENDED TO TREAT FRACTURES OF VARIOUS BONES, INCLUDING THE CLAVICLE, PELVIS, SCAPULA, LONG BONES(HUMERUS, RADIUS, ULNA, FEMUR, TIBIA AND FIBULA), AND SMALL BONES-LIKE METALCARPALS, METATARSALS AND PHALANGES. GPC DHS/DCS PLATE SYSTEM IS PROVIDED NON-STERILE. THE GPC DHS/DCS PLAT SYSTEM IS INTENDED FOR USE IN FIXATION OF FRACTURES OF THE PROXIMAL FEMUR. THE GPC DHS/DCS PLATE SYSTEM IS INDICATED FOR USE IN TROCHANTERIC, PERTROCHANTERIC, INTERTROCHANTERIC AND BASILAR NECK FRACTURE
    Device Description
    THE BONE PLATES.AND BONE SCREW SYSTEM AND DHS/DCS PLATE SYSTEM CONSIST OF NON-STERILE BONE PLANTE AND BONE SCREW IMPLANTS. THE PLATES ARE DEVICES WHICH ARE USED TO FASTEN THE BONES FOR THE PURPOSE OF FIXATION OF FRACTURED BONES. THE BONE PLATES CAN BE DISTINGUISHED IN TERMS OF THEIR FUNCTION, i.e. THE PLATE ON WHICH THIS IS TO BE FIXED. Generally there are following types of bone plates: - Dynamic Compression Type, - Tubular Type - Special (for particular bones) - Mini fragment - Used with Dynamic Hip screw and Used with Dynamic Condylar . Screw These bone plates are generally designed on the basis of the bone contour and anatomy. Following are further categories of bone plates: DCP (Small DCP, Narrow DCP, Lengthening Narrow, Broad DCP, Lengthening Broad Plates) Tubular Plates (Quarter Tubular, Semi Tubular and One Third Tubular Plates) Special Plates (L-Shaped, T-Shaped, Spoon, Lateral Tibial Head Buttress, Condylar Buttress, Hook, Cobra Head, Angled Plates for various Osteotomy locations. Reconstructions plates) Mini Fragment (Straight, L-Shaped, T-Shaped, condylar plates, reconstruction plates) DHS/DCS (DHS Barrel Plate with various angles and in short / large barrel length, DCS Plate) THESE DEVICE CAN BE MADE IN FOLLOWING MATERIALGRADES STAINLESS STEEL ALLOY in compliance to ASTM F 138, ASTM F 139 TITANIUM ALLOY in compliance to ASTM F 136 The GPC Bone Plates are divided mainly into Mini Fragment Plate system Small Fragment Plate System Large Fragment Plate System The thickness of these plates varies from 1.0mm to 6.0mm The width of these plates varies from 3.0mm to 17mm The length of these plates varies from 15mm to 360mm The number of holes of these plates vary from 2 to 22 holes The GPC Bone Screws are differentiated by the manner in which they are fastened on the bone, their function, their size and the type of bone they are intended to be used for. Four Types of Screws; Cortical (cortex) Screw Cancellous Screw Malleolar Screw Cannulated These screw variants can be provided with locking compression thread types as well as regular types. Type of Recess: Hexagonal Diameter Range: 1.5mm to 7.3mm Length Range: 6mm to 150mm DHS / DCS Plate system consists of a DHS Plate or DCS Plate (Dynamic Hip Screw Type or Dynamic Compression Screw Type) This plate is fastened on femoral shaft using 4.5mm cortex screw (self tapping) and the barrel is fastened using DHS Screw having diameter ranging from 12.5mm to 14.0mm Barrel Length: 25mm or 38mm Barrel Angle: 95 degree, 135 degree, 140 degree, 145 degree, 145 degree and 150 degree Compression is achieved using 4.0mm Diameter Compression Screw.
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