Canwell Medical Standard Monoaxial Pedicle Screw Titanium Surgical Spine Screws Cantsp with Ce, ISO and FDA for Posterior Thoracolumbar Spinal Fixation System

• Certification：CE, ISO9001
• Disinfection：Without Disinfection
• Color：Transparent
• Application：Spine
• Material：Titanium
• Certificate：ISO13485, ISO9001, Ce

=== Base Info ===

• Model NO.：CanTSP
• Standard：Standard , Reduction
• Axial：Monoaxial , Polyaxial
• Diameter：4.5, 5.0, 5.5, 6.0, 7.5, 8.5
• Transport Package：Cartoon
• Specification：Customized
• Trademark：Canwell,Customized
• Origin：Zhejiang
• HS Code：9021100000
• Production Capacity：10000,Month

=== Description ===
Product NameStandard Monoaxial Pedicle Screw titanium surgical screws priceMaterialThe CanTSP are made of Titanium alloy.ColorCustomizedStandard ISO 13485,ISO9001,QSR820,CEIndicationThe 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.Contraindications1.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.Instruments for CanTSP
CanTSP Instrument Set

Description	Qty.
Tap(4.5mm)	1
Tap(5.0mm)	1
Tap(5.5mm)	1
Tap(6.0mm)	1
Tap(6.5mm)	1
Rod Bender, left	1
Rod Bender, right	1
In-situ Bender, left	1
In-situ Bender, right	1
Self-retaining Break-off Driver	1
Stardrive screwdriver	1
Quick Coupling Plug driver	2
Reduction Screw Tab Breaker	1
Dual End Plug Starter(short)	2
Universal Spinal Screw Tray	1
Monoaxial Screwdriver	1
Reduction Monoaxial Screwdriver	1
Polyaxial Screwdriver	1
Reduction Polyaxial Screwdrive	1
Reduction Forceps	1
Extender	1
Lateral Translator	1
Plug Starter	1
Counter Torque Wrench	1
Instruments tray(TSP5.5)	1

3.CanTSP Instrument Set( for correction)

Description	Qty.
Wide blade Lamina Elevator	1
Narrow blade Lamina Elevator	1
Pedicle Elevator	1
Transverse Process Elevator	1
Hook Pusher for Implant Holder	1
Implant Pusher for Dual Purpose Instrument	1
Lateral Implant Holder	2
Dual Purpose Instrument	1
Universal Spinal Screw Tray	1
Instruments tray(TSP5.5 Correction)	1

Q: Would you please give some information on shipping mode and charges? 
A: Normally we send through courier, or post upon request from clients.

Q: Do you have ISO 9001, CE, or FDA approvals? 

 A: Yes, we are an ISO 9001:2008 and EN ISO 13485:2012 Certified Company. We have FDA Registrations and CE mark for many of our products.

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

Q: Can I buy products not shown but similar to your catalogue?
A: Of course you can, just send us pictures or samples. But this takes a little longer time for delivery.

Q: Do you have stock for listed products, or they are newly produced?
A: 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.