Orthopedic Spine Titanium Pedicle Screw, Spinal Screw Instrument

• Type: Instruments
• Application: Orthopedic
• Material: Stainless Steel
• Feature: Disposable
• Certification: CE, FDA, ISO13485, ISO9001
• Group: Adult
• Model NO.: CanFIX
• Medical Device Regulatory Type: Type 3
• Medical Devices Reg./Record No.: 9021100000
• Medical Devices Ad. Approval No.: 9021100000
• Color: Customized
• Certificate: ISO13485, ISO9001, Ce
• Transport Package: Cartoon
• Specification: Customized
• Trademark: Canwell/Customized
• Origin: Zhejiang
• HS Code: 9021100000
• Production Capacity: 1000/Month

Product Description

CanFIX Characteristics of The Products
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 from CANWELL MEDICAL CO., LTD. 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.

Product Name	Surgical Instrument Set for Pedicle Screw spinal fixation system implant orthopedic
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.

  



Instrument Set

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

Company Introduction>>

FAQ:

Q: Trading company or manufacturer?
A: We are manufacturer since 1994. Our location is in Jinhua, Zhejiang Province, East China. 
     2 hours by high-speed train from Shanghai.

Q: How's quality? Any Certificate? Regions of sales?
A: Our products are approved by CE/ISO13485.
     At present our main overseas markets are Asia, South America and Europe.

Q: Regional Distribution?
A: Yes we are looking for and welcome distribution. 
     Please contact us for discussion if you are interested to become our distributor.

Q: How long is delivery time?
A: Generally 7-15 days if stock available and 30-45 days if regular production needed.
    Depending on order quantity, product type, and other order factors and requirements.

Q: Samples available? Free or extra ?
A: We can accept sample order. With extra price.

Q: Terms of payment ?
A: T/T.

Q: Any OEM service?
A:  We can offer OEM service. Products can be made-to-order and with special requirements.