CE Certified Arthroscopy Implant: 5.5 mm Ligament Repair Suture Anchor System

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Product Description

Basic Info
Model NO.WZ-MDT-D
FeatureImplant
CertificationCE, ISO13485
ColorSilver and Orange
OEMAvailable
UsageOrthopedic Surgery
SterileEo Sterile
Warranty3 Years
FunctionConnect The Soft Tissue and Bone
Transport PackageBlister Box+ Box
HS Code9021100090
Production Capacity50000 Sets/Year
Product Description

CE Certified Arthroscopy Implant: 5.5 mm Ligament Repair Suture Anchor System consists of anchor, nonabsorbable suture and inserter.

High-Quality Materials: The anchor is manufactured from Ti6Al4V alloy (ISO5832-3:2016). The suture is made of high-strength ultra-high molecular weight polyethylene (UHMWPE) woven yarn (ASTM F2848-17), ensuring durability and biocompatibility.

Precision Components: The blue suture is dyed with FDA-approved material. The inserter features a stainless steel tip (ASTM F899-12b) and an ergonomic polycarbonate/ABS handle.

Packaging & Shipping
Specification
Frequently Asked Questions
1. What materials are used in the 5.5 mm suture anchor?
The anchor is made of high-grade Ti6Al4V alloy, and the sutures are constructed from ultra-high molecular weight polyethylene (UHMWPE), conforming to ISO and ASTM international standards.
2. Is the suture anchor system supplied sterile?
Yes, the system is EO (Ethylene Oxide) sterile and comes in a professional blister box and outer box packaging to ensure safety for orthopedic surgery.
3. What certifications does this product hold?
This ligament repair system is CE and ISO13485 certified, meeting global medical device quality and safety requirements.
4. What is the main application of this device?
It is specifically designed for arthroscopic and orthopedic surgeries to securely connect soft tissue (such as ligaments) to bone.
5. Does the inserter contact the human body?
The tip of the inserter is made of stainless steel (ASTM F899-12b) and is designed for contact, while the handle is made of polycarbonate and ABS for comfortable surgical handling.
6. What is the warranty period and production capacity?
The product comes with a 3-year warranty. Our production facility has a capacity of approximately 50,000 sets per year.

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