Osteora Osteora

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 cannot replace normal bone, the patient shall be told to conduct suitable recovery exercises, but overload 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 back-and-forth is forbidden, otherwise will potentially cause breaking and invalid.

6. The operating doctor shall have abundant clinical experience, and be familiar with inner fixation operation, inner implant and accessory devices.

Product System Showcase
Spinal Instrument Set Component
Spinal System Instruments
Pedicle Screw Assembly
System Screw Component Detail
Surgical System Component Guide
Certificates & Quality Standards
Certificate HD 60125623 0001

HD 60125623 0001

Certificate EN ISO 13485:2016

EN ISO 13485:2016

Certificate EN ISO 13485:2016 Duplicate

EN ISO 13485:2016

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VR Virtual Showroom Tour
Surgical System Manufacturing Info
Orthopedic Instruments Processing
Production Facility View
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Frequently Asked Questions

Q: Would you please give some information on shipping mode and charges?

A: Normally we send through courier, or post upon request from clients. Shipping charges are calculated based on weight and standard delivery terms.

Q: Do you have ISO 9001, CE certifications?

A: Yes, products are manufactured under strict ISO 9001 and EN ISO 13485 standards. CE marks are available for many of the core orthopedic product lines.

Q: What is the minimum order value that we can place?

A: We expect standard minimum orders to be at least US$1000. However, we understand that customers may need to place smaller sample orders initially in order to test and market the products. Samples are available on request.

Q: Can I buy products not shown but similar to your catalog?

A: Yes, you can. Simply send us pictures or samples. Please note that custom production items may require a slightly longer time for delivery.

Q: Do you maintain stock for listed products, or are they newly produced?

A: Generally, stock is maintained for standard listed products with monthly production runs. However, availability depends on sales conditions. Please contact our representatives for accurate inventory information.

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