ISO 13485 Certified Medical Titanium Plate for Orthopedic Implants with Case Study

Name: "ISO 13485 Certified Medical Titanium Plate for Orthopedic Implants with Case Study"
Rating: 5 (288 reviews)

Quantity:

SKU: 7534199425

Model: GR1,GR2,GR4,GR5 ELI, Ti 6AL4V ELI, GR23

Product Details

ISO 13485 Certified Medical Titanium Plate for Orthopedic Implants

Summary: This medical titanium plate is manufactured under ISO 13485 certification, specifically for orthopedic implants. It offers high precision (±0.005mm tolerance), excellent biocompatibility, and fatigue resistance, with proven success in real-world applications.

Key Selling Points

✔ ISO 13485 certified medical device quality management system
✔ High precision with 0.005mm tolerance for critical implant components
✔ Excellent fatigue resistance for long-term safe and stable use
✔ Proven in Brazilian surgical implant manufacturer's application
✔ Full-process quality control from raw materials to finished products

Technical Specifications

Grade	GR1, GR2, GR4, GR5 ELI, Ti-6Al-4V ELI, GR23
Standard	ASTM F136, ISO 5832-3, ASTM F67, ISO 5832-2
Thickness	0.3–50.0 mm
Width × Length	100 mm × 2000 mm
Process	Hot rolled and cold rolled
Microstructure	Class A1-A3

Models and Options

Available in multiple grades and finishes. Custom thickness and width within 0.3-50mm can be accommodated.

Materials and Structure

Produced from pure titanium or titanium alloys, with strict control of chemical composition, mechanical properties, and surface quality.

Applications

Orthopedic implants
Bone plates
Dental implants
Artificial joints

Case Study

A Brazilian surgical implant manufacturer used this plate for artificial joints, bone screws, and dental implants, reporting excellent biocompatibility and fatigue resistance.

FAQ

What is the MOQ?

10 kg.

What certifications do you have?

ISO 13485, ISO 9001, EN9100, and ISO/IEC 17025 lab accreditation.

Can you provide material test certificates?

Yes, each batch includes MTC and full inspection per ASTM/ISO standards.

Do you support third-party inspection?

Yes, SGS and BV are available upon request.

What is the delivery method?

FOB, CIF, or EXW.

Can you customize dimensions?

Yes, we can accommodate custom sizes within the standard range.

Inquiry Information

For pricing and delivery, contact us at sales@asiatitan.com or WhatsApp +86 13892862195.

Image: iso-13485-titanium-plate-orthopedic.png – Certified medical titanium plate with case study.