Product Description
The Suture Anchor System is a precision-engineered orthopedic solution consisting of an anchor, nonabsorbable suture, and inserter. The anchor is constructed from high-grade Ti6Al4V alloy, strictly adhering to ISO5832-3 standards.
Key Material Features:
- Suture: Crafted from ultra-high molecular weight polyethylene (UHMWPE) without coating, meeting ASTM F2848-17 requirements.
- Safety: Blue sutures are dyed with FDA-approved materials for clear intraoperative visibility.
- Inserter: Human-contact parts are made of surgical-grade stainless steel (ASTM F899), while the ergonomic handle utilizes durable polycarbonate and ABS.
Manufacturing Excellence
Our facilities include a Class 100,000 clean workshop and a Class 10,000 purification laboratory. We maintain full-cycle capabilities in R&D, manufacturing, and sales of surgical supplies, ensuring that every product complies with international quality benchmarks including CE certification and ISO 13485 standards.
Frequently Asked Questions
Are you a trading company or a manufacturer?
We are a professional manufacturer with our own dedicated production facilities and a specialized R&D team focused on orthopedic innovation.
Do you provide OEM services?
Yes, we offer comprehensive OEM services, including custom design and specialized packaging solutions tailored to your specific brand requirements.
Can I request a sample before placing a bulk order?
Certainly. We provide samples for quality evaluation and clinical review. Please contact our team to discuss specific sample details and logistics.
What certifications do your products carry?
All products are fully compliant with internationally recognized standards, holding CE and ISO 13485 certifications to ensure global medical reliability.
What are the advantages of your orthopedic instruments?
We offer over 20 years of industry expertise, a full range of matching instruments, and flexible manufacturing capabilities to meet diverse surgical needs.
What is the typical delivery time?
Delivery times are based on the order volume and payment confirmation. We strive to maintain efficient production cycles to meet urgent medical demands.