Canwell Laminoplasty Fixation System Orthopedic Spinal Implant

Customization: Available
Certification: FDA, CE, ISO9001
Disinfection: Without Disinfection

Product Description

Basic Information
Model NO.
Laminoplasty Fixation System
Color
Yellow / Customized
Application
Spine
Material
Titanium Alloy
Certificate
ISO13485, ISO9001, CE
Capacity
1000/Month
Product Description
Laminoplasty Fixation System Orthopedic Spinal Implant

The Laminoplasty Fixation System is a comprehensive spinal solution designed for rigid stabilization across various configurations. Each construct is engineered to be tailor-made for individual clinical cases. The system components include high-precision screws, rods, and crosslinks, all manufactured from premium Titanium alloy conforming to ASTM F136 standards.

Product Name Laminoplasty Fixation System
Material Titanium Alloy (High Biocompatibility)
Standard ISO 13485, ISO9001, QSR820, CE
Clinical Indications

Provides stabilization and immobilization of spinal segments for:

  • Trauma (fracture or dislocation)
  • Curvatures (scoliosis, kyphosis, and/or lordosis)
  • Spinal tumors
  • Failed previous fusion or pseudarthrosis
  • Spinal stenosis
! Contraindications
  • Severe osteoporosis
  • Known sensitivity to implant materials
  • Uncontrolled patient behavior or metabolism dysfunction
  • Immunology dysfunction
  • Spinal cord or nerve damage
Safety & Precautions

1. MR Environment: Safety and compatibility in the MR environment have not been evaluated. Scanning patients with this device may result in injury.

2. Removal: Inner implants should be removed after the treatment period or expiry based on clinical examination.

3. Post-Op Care: Implants do not replace normal bone. Patients must follow recovery exercises; overload and acute movements are forbidden.

4. Compatibility: Do not mix components from different materials or manufacturers.

5. Handling: Rods can be shaped using specific tools to match the spinal column, but repeated bending is prohibited to prevent breakage.

Product Visuals
Frequently Asked Questions
What material is used for the Laminoplasty Fixation System?
The system is manufactured from high-grade Titanium alloy conforming to ASTM F136, ensuring excellent biocompatibility and mechanical strength for spinal stabilization.
What certifications do these orthopedic implants hold?
Our products are fully compliant with international quality standards, including ISO 13485, ISO 9001, and CE certification.
Can the system be used for pediatric cases?
The system is indicated for specific spinal instabilities and deformities. However, it is not intended for pedicle screw fixation above the T8 vertebrae. Clinical determination by a surgeon is required.
What is the typical delivery time for orders?
Generally, delivery takes 7-15 days if stock is available. For regular production orders, the lead time is approximately 30-45 days, depending on quantity and specifications.
Do you offer OEM or customized manufacturing services?
Yes, we provide comprehensive OEM services. Products can be made-to-order to meet specific clinical requirements or branding needs.
Are samples available for evaluation?
We accept sample orders for quality evaluation and testing. Please note that sample orders may involve additional pricing and shipping costs.

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