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The Syntec Dental Implant is intended to be surgically placed in the bone of the upper or lower jaw arches. To provide support for prosthetic devices, such as to restore the patient's chewing function, and artificial teeth. It is intended for delayed loading.

The Syntec Dental Implant provides Titanium Alloy (commercially followed by ASTM F136) intended to be surgically placed in the bone of the upper or lower jaw arches. To provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of implant, cover screw, healing abutment screw and abutments. The Syntec Dental Implant is for one and two stage surgical procedures. Its materials, dimensions, and intended use are similar to devices currently marked worldwide. The range of implant in diameter is from 3.4mm to 4.8mm and in length from 8.0mm to 14.0mm. The range of abutment in diameter is from 4.5mm to 6.5mm, and in length from 5.5mm to 12.0mm.

Syntec OS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of the following: - Degenerative disc disease . - Spondylolisthesis . - Trauma (i.e., fracture or dislocation) . - Spinal stenosis . - Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) ● - . Tumor - . Pseudoarthrosis - . Failed previous fusion

The Syntec OS Spinal Fixation System is manufactured from titanium alloy (as per ASTM F136) and is designed with various sizes to provide stabilization as an adjunct to spinal fusion surgery. Surgeons can use our top loading technique through the screws and rods to fix the components into a U-shaped opening

Syntec Osteo-plate and screw Fixation is intended to be used on small bones or large bones for fracture fixation, including the fractures of clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).

Those are designed with various sizes of partially and fully threaded to satisfy with different kinds of fractures as using on small bones or large bones. The subject components are plates available in width from 3.8mm to 17.5mm, in total length from 15mm to 319mm and the hole numbers are 2 to 22 holes. The threads of the screws are available in diameters from 2.4mm to 7.3mm, and in length from 6mm to 180mm. Those screws have been designed for fitting on different symptoms of fractures and the plates have been designed to distribute for local anatomies and should be necessary to be used with its intended screws. Basically, the screws used to fasten plates onto bone, or, as lag screws, to hold together fragments of bone. We have totally the same kinds of the screws and plates as the predicate devices' functions, but with self-tapping or self-drilling to promote the operation efficiency. Besides this, we have another alternative screws and plates which are designed with locking head of the screws taken place with the traditional screw head, and threaded aside locking hole of the plates taken place with the aside plain hole of the plates.

The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

The screws are manufactured from commercially SUS316L ( stainless steel ) and Ti-6AL-4V ( titanium alloy ) . The screws are available with thread diameter are from 1.3mm to 2.0 mm, and total lengths from 5mm to 17mm. There is a pair of self-tapping flutes and self-drilling flutes for easy insertion and removal. The design of smooth curve surface of screw head is comfortable to patients, and the screws with or without a 0.65mm diameter hole can supply different orthodontic methods for orthodontists.

The bone plates and screws are provided non-sterile. The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).

The plate is manufactured from commercially 316LS Stainless Steel which in conformance with ASTM F138 and an alternative material which is Pure Titanium. The plates designed are from 1.5mm to 6.5mm thickness, from 6.5mm to 17.5mm width, and are available variously in length from 24.0mm (2 holes) to 394.0mm (22 holes). It should assembly with the same screw that was the predicate device in concurrence by FDA, (K983495).

The Unreamed Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(femur, and tibia) for the fixation of fractures.

The interlocking system makes up of Femoral, Tibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nail. The interlocking nails have the same features such as: Dynamic locking: Using the proximal oval hole permits axial loading with A rotational stability. A Anatomical design: Femur: The 1.6m radius of the Unreamed Femoral Nail corresponds closely with the average anatomical curvature of the femur. Tibia: The curvature of 8° in the upper third of the Unreamed Tibial Nail allows for easy insertion and good anatomical fit. A Distal locking: Through two medial holes, additional locking is also possible in the anatomical seat. Easy insertion: The curvature of the posterior aspect of the nail reduces damage to the interior posterior cortical surface during insertion. The dimension of the unreamed interlocking nail ranges in diameter from 8 to 12 mm and total length 255 to 480 mm. The locking bolt screws have high strength, self-tapping and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9, 4.9, and 5.0mm and total length 20 to 125 mm.

The Small Orthopedic Fixation System is provided non-sterile. The implants by the External Fixation Instrument may be used for highly comminuted closed fracture of hand, wrist, foot and tarsus ; for severe open fractures; for complex soft-tissue damages; or for dislocated joint fractures.

The Small Orthopedic Fixation System makes up of instrument and implants. The instrument is utilized with the implants. The implants are divided two kinds of styles: Schanz Screw, and Kirschner Wire. The dimension of the Schanz Screw ranges in thread diameter from 1.6 to 3.0 mm, thread length 15 mm, and total length 150, 200 mm; The dimension of Kirschner Wire with Threaded Tip ranges in thread diameter from 3.0/4.0 mm, total length from 80 mm.

The Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(humerus, femur, and tibia) for the fixation of fractures.

The interlocking system makes up of Humeral, Fibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nails have the same features such as: Proximal locking: Choice of two oval holes for static locking(only three holes for humerus) secures the rotational and axial stability. Anatomical design: Humerus: The curvature of 5° in the upper third of the Reamed Humeral Nail allows for easy insertion and good anatomical fit. Femur: The 1.88m radius of the Reamed Femoral Nail corresponds closely with the average anatomical curvature of the femur. Tibia: The curvature of 15° in the upper third of the Reamed Tibial Nail allows for easy insertion and good anatomical fit. Distal locking: Through two medial holes, additional locking is also possible in the anatomical seat. Easy insertion: The curvature of the posterior aspect of the nail reduces damage to the interior posterior cortical surface during insertion. The dimension of the interlocking nail ranges in diameter from 7 to 16 mm and total length 200 to 480 mm. The locking bolt screws have high strength, no tapping necessary and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9 to 6.4 mm and total length 20 to 100 mm.

The titanium alloy Mini plate is provided non-sterile. The device is intended to treat fractures of various bones, including the clavicle, scapula, pelvis, calcaneus, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and plialanges).

The Mini plate is device, which is fastened to bone for purpose of providing fixation. The device is principally differentiated by its function. Thus there is various types and sizes of bone fixation plates. The Mini plate is geometry shape as follows: Straight, L-shaped, T-shaped, H-shaped, Condylar, Cloverleaf, Calcaneal, and Straight Reconstruction. The plate must be used for various sizes of screw onto bone fixation. The device range in thickness from 0.9 to 2.8 mm, width from 3.8 to 15.2 mm, length from 17 to 262 mm, and hole number from 3 to 22 holes.

The DHS/DCS Plate System is provided non-sterile. The device may be used for fixation of fractures of the proximal femur, such as femoral neck, trochanteric, pertrochanteric, or intertrochanteric zones.

The system makes up of DHS/DCS Plates, DHS/DCS Screw, DHS/DCS Compression Screw, and 4.5 mm Cortex Screw (self-tapping). The DHS Plates are available with barrel length 25 mm and 38 mm, and barrel angles 135°, 140°, 145°, and 150° . The standard barrel length is 38 mm. Otherwise, the self-tapping 4.5 mm Cortex Screw may be used to fix the DHS/DCS Plates to the femoral shaft. The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 26 mm and outer diameter 4.0 mm. The thread of DHS/DCS Screw has a buttress type. The DHS/DCS Screw is available with thread length 22 mm, total length from 50 to 145 mm, outer diameter 12.5 mm, and shaft diameter 8.0 mm.