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CANWELL Titanium Spine Surgical Instruments Set for Posterior Thoracolumbar Fixation System

Product Description

Spinal Fixation System Banner

The Spinal Fixation System consists of a variety of shapes and sizes of rods, hooks, screws, crosslink and connecting components etc., as well as implant components. The Spinal Fixation System, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Spinal Fixation System can be used with the Spinal Fixation System. The components of the system include: screws, rods, crosslink and so on. Care should be taken so that the correct components are used in the spinal construct. The Spinal Fixation System is made of Titanium alloy which conforms to ASTM F136. To achieve best results, do not use any of components from any other device systems or manufacturers unless specifically allowed to do so. As with all orthopaedic implants, none of the Spinal Fixation System components should ever be reused under any circumstances.

Product Name New Products Spinal Surgical Instruments Set For spinal pedicle screw rod crosslink Hook System
Material Titanium alloy
Color Customized
Standard ISO:13485/ISO:9001/FDA
Brand OEM
Indication 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.

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.
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.
Spinal Fixation Product Detail 1
Spinal Fixation Product Detail 2
Spinal Fixation Product Detail 3
Spinal Fixation System Technical Drawing
Spinal Fixation System Specifications
Certificate HD 60125623 0001
HD 60125623 0001
Certificate EN ISO 13485:2016 1
EN ISO 13485:2016
Certificate EN ISO 13485:2016 2
EN ISO 13485:2016
Manufacturing Standards Certificate
Quality Management System Process
Cleanroom Production Line
Advanced Testing Instrumentation
Global Supply Chain Logistics
Frequently Asked Questions
Would you please give some information on shipping mode and charges?
Normally we send through courier, or post upon request from clients.
Do you have ISO 9001, CE ?
Yes, we are an ISO 9001:2008 and EN ISO 13485:2012 Certified Company. We have CE mark for many of our products.
What is the minimum order that we can place?
We expect your minimum orders to be least at US$1000. However, we understand that customers need to place smaller samples orders in the beginning in order to test market our products . Samples against cost are available on request.
Can I buy products not shown but similar to your catalogue?
Of course you can, just send us pictures or samples. But this takes a little longer time for delivery.
Do you have stock for listed products, or they are newly produced?
Generally, we have stock for every listed products, which were produced monthly. But it depends on our sales condition. Better to ask our salesman for accurate inventory information.

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