| Type: | Instruments |
|---|---|
| Application: | Orthopedic |
| Material: | Stainless Steel |
| Feature: | Disposable |
| Certification: | CE, ISO13485, ISO9001 |
| Group: | Adult |
| Customization: |
|---|
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Audited Supplier | Product Name | Surgical Instrument Set for Pedicle Screw spinal fixation system names of medical instruments |
| Material | The CanFIX are made of stainless steel |
| Color | Customized |
| Standard | ISO 13485,ISO9001,QSR820,CE |
| Contraindications | 1.Severe osteoporosis sufferer; 2.Sensitive sufferer on implant material known or under suspicion; 3.Sufferer under behaviour un-controlled; 4.Sufferer with metabolism and immunology dysfunction; 5.Spinal cord or nerve damnification; 6.Other sufferers not suitable for spinal inner operation according to clinical determination. |
| Indications | The device provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1)trauma (i.e. fracture or dislocation), (2)curvatures (scoliosis, kyphosis, and/or lordosis), (3)spinal tumor, (4)failed previous fusion, (5)pseudarthrosis, (6)spinal stenosis. It is not intended for pedicle screw fixation above T8. |
| Precautions: | 1.The spinal fixation system has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of spinal fixation system in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. 2.Inner implant shall be taken out in time after expiry or cure according to clinical examination. 3.The inner implant can not replace normal bone, the patient shall be told to conduct suitable recovery excises, but over load and acute movement is forbidden. 4.Do not use the inner implant with different materials or from different manufacturers together. 5.Rod of spinal fixation system can be transfigured if necessary, to obtain the shape similar with spinal column, but particular tools are necessary, and bending come-and-go is forbidden, otherwise will potentially cause breaking and invalid. 6.The operation doctor shall have abundant clinical experience, and familiar with inner fixation operation, inner implant and accessory devices. |
| NO. | P.N | Description | Qty. |
| 1 | 212010001 | Awl Length 228mm | 1 |
| 2 | 212010002 | Pedicle Probe, Ø3.0mm, straight | 1 |
| 3 | 212010003 | Pedicle Probe, Ø3.5mm, straight | 1 |
| 4 | 212010004 | Screw Tab Breaker | 1 |
| 5 | 212010006 | Universal Screw Driver | 1 |
| 6 | 212010007 | Rod Pusher | 1 |
| 7 | 212010008 | Depth-limited Awl | 1 |
| 8 | 212010009 | Feeler for Screw Channel, curved | 1 |
| 9 | 212010010 | Quick Connect T-Handle | 2 |
| 10 | 212010011 | Monoaxial Screwdriver | 1 |
| 11 | 212010012 | Polyaxial Screwdriver | 1 |
| 12 | 212010013 | Rod Rotation Wrench, hexagonal | 1 |
| 13 | 212010014 | Rod Holder | 1 |
| 14 | 212010015 | Rod Bender | 1 |
| 15 | 212010016 | Parallel Compression Forceps | 1 |
| 16 | 212010017 | Parallel Distractor Forceps | 1 |
| 17 | 212010018 | Power Grip | 1 |
| 18 | 212010019 | Compression Sleeve | 2 |
| 19 | 212010020 | Counter Torque Wrench | 1 |
| 20 | 212010021 | Pedicle Marker, right | 3 |
| 21 | 212010022 | Pedicle Marker, left | 3 |
| 22 | 212020004 | Plug Starter | 2 |
| 23 | 212030022 | Feeler for Screw Channel, straight | 1 |
| 24 | 212012000 | instrument tray | 1 |
| 25 | 212013000 | Implant Tray | 1 |
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