Medical-Grade CNC Machined Implant Parts - Titanium, ISO 13485
Product Summary: Our medical-grade CNC machined parts are precision manufactured from biocompatible titanium and other alloys, meeting ISO 13485:2016 standards. With over 20 years of experience in medical implant processing, we deliver components for human body implants with superior precision and long life. Our facility is certified for medical device quality management.
Key Selling Points
- ISO 13485 Certified: Full quality management system for medical devices (certificate UKZB24MD30131ROS).
- Biocompatible Materials: Titanium, stainless steel 316L, and other implant-grade alloys.
- Ultra-Precision: Tolerances down to ±0.001mm for implant fit and safety.
- Proven Case Study: Supplied 10 tons of implant parts to a Turkish medical factory over 20 years, achieving excellent biocompatibility and longevity.
Technical Specifications
| Parameter | Value |
|---|
| Model | MA05-Med |
| Machining Capability | 3-axis, 4-axis, 5-axis CNC Milling & Turning |
| Tolerance | ±0.001mm ~ ±0.01mm |
| Surface Finish | Ra 0.8 ~ Ra 3.2 (Standard); Polishing, Anodizing, Plating optional |
| Materials | Titanium (Ti-6Al-4V ELI), Stainless Steel 316L, Cobalt-Chrome |
Models and Options
Model MA05-Med designed for medical implant applications. Options for surface treatments that enhance osseointegration.
Materials and Structure
Biocompatible materials such as Ti-6Al-4V ELI and 316L stainless steel ensure compatibility with human tissue. All materials are 100% traceable.
Applications
- Human body implants (knee, hip, dental)
- Surgical instruments
- Medical device components
Customization
Custom implant geometries based on patient anatomy or design specifications. DFM support available.
Case Study
A Turkish medical implant processing factory has been using our CNC machined titanium parts for over 20 years, with a total volume of 10 tons. The parts demonstrate biocompatible material compatibility, superior medical-grade precision, and long lifetime.
FAQ
1. Are your medical parts ISO 13485 certified?
Yes, we hold ISO 13485:2016 certificate number UKZB24MD30131ROS.
2. What materials are suitable for implants?
We machine titanium (Ti-6Al-4V ELI), 316L stainless steel, and cobalt-chrome alloys.
3. What is the MOQ for medical parts?
MOQ is 2 units.
4. Can you provide biocompatibility documentation?
Yes, we supply material certificates and biocompatibility test reports upon request.
5. How do you ensure sterility?
Parts are cleaned and packaged per customer requirements; sterilization is done by the customer.
6. What payment terms?
30% deposit, 70% before shipment.
7. Do you have experience with long-term implant parts?
Yes, we have a 20-year case study with a medical implant factory in Turkey.
Inquiry Information
Contact Yolanda at sales@kobomaterials.com or WhatsApp +86 15190095921.
Image Filename and Alt Suggestions
Main Image 1: medical-implant-cnc-parts-ma05-med-1.jpg - Alt: "Medical-grade titanium CNC machined implant part MA05-Med"
Main Image 2: medical-implant-cnc-parts-ma05-med-2.jpg - Alt: "Precision machined orthopedic implant component"
