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510(k) Data Aggregation

    K Number
    K203811
    Device Name
    GPC Intraheal Intramedullary Nailing System
    Date Cleared
    2022-02-10

    (409 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    GPC Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GPC Intraheal Intramedullary Nailing System are provided non-sterile. GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given below: Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below: - To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers, Impending Pathologic Fractures, Nonunions and Malunions. Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below: Short Nail Indications: - - Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion . - and tumor resections . Long Nail Indications: - - . Indications may include fractures resulting from trauma, nonunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures. Elastic Nails: The Elastic Nail is indicated for fixation of diaphyseal fractures of the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures and lower extremity fractures in paediatic or small statured patients. In paediatric application, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate. K-Wires: K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system All implants are for single use only.
    Device Description
    GPC Intraheal Intramedullary Nailing System are manufactured in various shapes and sizes. The intramedullary nails are fixed with corresponding sizes of locking bolts and end caps. GPC Intraheal Intramedullary Nailing System are manufactured using stainless steel or titanium materials for surgical implant applications. The different sizes and model numbers of GPC Intraheal Intramedullary Nailing System are based on the site of application such as fixation or reconstruction of the bones. These intramedullary nails are available in different diameters and lengths to suit the patient anatomy and size of the bones. GPC Intraheal Intramedullary Nailing System are typically divided into following three categories: - 1. Femoral Nails and corresponding locking bolts and end cap for fixation - 2. Elastic Nails and corresponding end caps for fixation - 3. K wire for fixation The specific names of the GPC Intraheal Intramedullary Nails are as given below: Multi Angle Femoral Nail Proximal Hip Stabilizing Nail 3 (Also called as PHN3) Elastic Nail K.Wire
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    K Number
    K210198
    Device Name
    GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive
    Date Cleared
    2022-01-07

    (347 days)

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

    GPC Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The system is indicated for use in adult patients only. All implants are for single use only.
    Device Description
    GPC Variable Angle Locking Two Column Volar Distal Radius Plates are machined metal plates designed for fixation of various fracture modes of the distal portion of the Variable Angle Locking Two Column Volar Distal Radius Plates allow fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. The variable angle locking mechanism improves the plate-screw construct stability. GPC Variable Angle Locking Two Column Volar Distal Radius Plates are manufactured using titanium material for surgical implant applications. Following are the types of the GPC Variable Angle Locking Two Column Volar Distal Radius Plates: - Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 22 mm, 6 Head Holes (with option of Left and Right Variants) - Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 25.5 mm, 7 Head Holes (with option of left and right variants) - Variable Angle Locking Two Column Volar Distal Radius Plate- Narrow, Width 19.5 mm, 6 Head Holes (with option of left and right variants) Corresponding Screws for fixation: - Variable Angle Locking Screw 2.4 mm, Star drive Lengths: 6mm to 30mm in 2mm increments - FixLOCK Self-Tapping Screw 2.4 mm, Star drive Length 6mm to 30mm in 2mm increments - Self-Tapping Cortex Screw 2.7 mm, Star drive Length: 12mm to 24mm These implants are supplied non-sterile, the products have to be sterilized prior to use.
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    K Number
    K163096
    Device Name
    GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
    Date Cleared
    2017-03-31

    (147 days)

    Product Code
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    GPC MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is intended for use in the noncervical spine. The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is used as an adjunct to fusion, using autograft or allograft, in the treatment of the following instabilities and deformities in skeletally mature patients: 1. Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of disc confirmed by history & radiographic studies) 2. Spondylolisthesis 3. Trauma (Fracture or Dislocation) 4. Spinal Stenosis 5. Scoliosis, Kyphosis and/or lordosis 6. Pseudoarthrosis 7. Failed Previous Fusion The system is indicated for use in adult patients only. All implants are for single use only.
    Device Description
    The Monoaxial & Polyaxial screw consists of a body, bushing, and ball head screw. Inner Screw, rods and transverse connectors assemblies complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post or monoaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned. The Screws, Rods &Transverse Connectors are fabricated from Titanium. The system contains several models based on the size of the device and application site such as fixation/reconstruction spine. - Single Lock Monoaxial Screw - Single Lock Polyaxial Screw - Transverse connector - Rod The diameter of these screw varies from 4mm to 7mm with length 25mm to 50mm. The corresponding connector are small & large in size. The diameter of Rod is 5.5mm with length 75mm to 150mm These implants are supplied non-sterile; the products have to be sterilized prior to use.
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    K Number
    K143245
    Device Name
    GPC Intramedullary Nailing Systems
    Date Cleared
    2015-09-30

    (322 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    GPC MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1. Indication for Use: Multi Angle Tibial Nail is intended to stabilize fracture of the proximal & distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions & nonunions. 2. Indications for Use: Ga-mma Nail is indicated for use in stabilizing various types of intertrochanteric fractures of proximal femur.
    Device Description
    The GPC Intramedullary Nailing Systems include intramedullary nails and corresponding screws/end caps/locking bolts for fastening these intramedullary nails to the fractured bones.
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