KOBO Advanced Materials produces custom medical CNC machined components for human implants, certified to ISO 13485. Using biocompatible titanium (Grade 5) and stainless steel 316L, we achieve ±0.001mm precision with Ra 0.8 finish. A 20-year partnership with a Turkish implant factory delivered 10 tons of high-quality parts.
Key Selling Points
ISO 13485 Certified: Medical device quality management system (certificate UKZB24MD30131ROS) ensures compliance with global regulations.
Biocompatible Materials: Titanium Grade 5 (Ti-6Al-4V) and 316L stainless steel offer excellent corrosion resistance and tissue compatibility.
±0.001mm Precision: Tight tolerances essential for implant fit and longevity, reducing rejection rates.
Proven Medical Case: Supplied 10 tons of implant components to a Turkish medical device manufacturer over 20 years.
Surface Treatments: Passivation and polishing (Ra 0.8) for smooth, bio-friendly surfaces.
Model MA01 base; custom geometries for orthopedic implants, spinal components, and surgical instruments.
Materials and Structure
Primary material: Titanium Grade 5 (high strength, biocompatible). Also available: 316L stainless steel and PEEK for specific applications. Structure optimized for osseointegration and load-bearing.
Applications
Human body implants (knee, hip, dental), surgical instruments, and medical device components. Suitable for EU, USA, Australia, and Asia markets.
Case Study
Client: Medical implant processing factory in Turkey (20-year partnership)
Quantity: 10 tons of implant components
Results: Biocompatible material compatibility, superior medical-grade precision, long service life. ISO 13485 compliance ensured regulatory approval.
Customization
We offer full custom machining per your drawings. MOQ: 2 units. Pre-shipment testing available. Payment: 30% deposit, 70% before shipment.
FAQ
Q: Are your materials fully traceable?
A: Yes, all materials are 100% traceable with full certification.
Q: What is the lead time for medical parts?
A: Typically 3-5 weeks, depending on complexity and material availability.
Q: Do you offer surface polishing for implants?
A: Yes, we achieve Ra 0.8 surface finish for smooth implant surfaces.
Q: Can you machine PEEK for medical applications?
A: Yes, we machine PEEK and other engineering plastics.
Q: Do your certifications cover EU and US markets?
A: Yes, ISO 13485 is recognized globally, and our products meet EU MDR and FDA requirements.
Q: What is your production capacity?
A: Annual output of 200 tons for CNC machined parts.
Q: How do you ensure quality?
A: We have in-house testing and independent third-party inspections; all products receive pre-shipment checks.
Q: Can I get samples first?
A: Yes, samples are available upon request.
Inquiry Information
Contact Yolanda: sales@kobomaterials.com | Tel/WhatsApp: +86 15190095921. Address: Room 507, Building 1, No.190 Jinfeng road, New District, Suzhou, China.
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