Custom Precision CNC Machined Titanium Medical Implant Parts - ISO 13485 Certified
KOBO Advanced Materials Co., Ltd offers precision CNC machined titanium medical implant parts manufactured from biocompatible Grade 5 (Ti-6Al-4V) titanium. Our components achieve tolerances as tight as ±0.001mm using 5-axis milling and turning, backed by ISO 13485:2016 quality management for medical devices. With over 20 years of experience supplying a Turkish implant factory with 10 tons of parts, we deliver superior biocompatibility and long service life.
Key Selling Points
- ±0.001mm tolerance for critical implant geometries (source: product parameters)
- 5-axis CNC milling & turning ensures complex shapes for medical implants (source: product parameters)
- Electropolishing and passivation surface treatments enhance biocompatibility (source: product parameters)
- ISO 13485:2016 certified medical device quality system (source: certificate)
- Proven 20-year partnership with Turkish implant processor (source: case study)
Technical Specifications
| Parameter | Value |
|---|
| Material | Titanium Grade 2, Grade 5 (Ti-6Al-4V) |
| Tolerance | ±0.001mm ~ ±0.01mm |
| Surface Roughness | Ra 0.8 ~ Ra 3.2 (standard) |
| Surface Treatment | Passivation, Electropolishing, Anodizing, Plating, Polishing |
| Machining Capability | 3-axis, 4-axis, 5-axis CNC Milling & Turning |
| Certification | ISO 13485:2016 (GB/T 42061-2022), ISO 9001:2015 |
Models and Options
Standard model MA02 serves as base. Custom models available per design. Options include multiple titanium grades (Grade 2, Grade 5), various surface finishes, and different axis configurations.
Materials and Structure
Biocompatible Titanium Grade 2 (commercially pure) and Grade 5 (Ti-6Al-4V) are used. All materials are 100% traceable with full certification, verified through in-house and third-party testing.
Applications
Human body implants, orthopedic & implant devices, surgical instruments, diagnostic equipment, patient care equipment, lab & research equipment.
Customization
We offer custom designs per customer drawings. MOQ is 2 units. Payment: 30% deposit, 70% before shipment. Delivery: FOB/CIF. Pre-shipment testing accepted.
Case Study
Client: Turkish medical implant processing factory
Quantity: 10 tons
Application: Human body implants
Duration: 20 years
Results: Biocompatible material compatibility, superior medical-grade precision, long lifetime
FAQ
- What is the minimum order quantity?
- 2 units.
- Do you have ISO 13485 certification?
- Yes, we are certified under GB/T 42061-2022/ISO 13485:2016, certificate number UKZB24MD30131ROS.
- What tolerances can you achieve?
- ±0.001mm to ±0.01mm depending on part complexity.
- Which titanium grades do you use?
- Grade 2 (CP) and Grade 5 (Ti-6Al-4V).
- Can you handle complex 5-axis parts?
- Yes, we have 3/4/5-axis CNC milling and turning capabilities.
- What surface treatments are available for medical parts?
- Passivation, electropolishing, anodizing, plating, and polishing.
- How do you ensure quality?
- We have ISO 13485 system, in-house testing, and third-party inspection. All materials traceable.
- What is the typical lead time?
- Please contact us for lead time based on order quantity and complexity.
Inquiry Information
Contact Yolanda at sales@kobomaterials.com or +86 15190095921 (WhatsApp). Address: Room 507, Building 1, No.190 Jinfeng road, New District, Suzhou, Jiangsu, China 215000. Website: www.kobomfg.com
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