Titanium Suture Anchor Sports Medicine Rotator Cuff Repair Elbow Repair Suture Anchor System

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Product Description

Basic Information

Model NO.:
WZ-MDT
Feature:
Implant
Certification:
CE, ISO13485
Color:
Silver and Orange
OEM:
Available
Usage:
Orthopedic Surgery
Sterile:
Eo Sterile
Warranty:
3 Years
Weight:
0.3kg
Function:
Connect The Soft Tissue and Bone
Capacity:
50000 Sets/Year
HS Code:
9021100090

Product Description

The Suture Anchor System consists of an anchor, nonabsorbable suture, and inserter. The anchor is constructed from high-quality Ti6Al4V alloy, meeting ISO5832-3:2016 standards for surgical implants. The accompanying suture is made of ultra-high molecular weight polyethylene (UHMWPE) material without coating, woven from multiple UHMWPE yarns in compliance with ASTM F2848-17. The blue suture variant uses FDA-approved coloring material (code 73.1015). The inserter features a stainless steel tip (ASTM F899-12b) for surgical precision, while the handle is ergonomically crafted from polycarbonate and ABS material.

Suture Anchor System Component
Suture Anchor System Detail

Packaging & Shipping

Sterile Packaging
Shipping Box

Specification

Product Specification Table

Frequently Asked Questions

What materials are used in the anchor?
The anchor is made of high-strength Ti6Al4V alloy, which complies with the international ISO5832-3:2016 standard for surgical implants.
Is the suture material bio-compatible?
Yes, the suture is made of ultra-high molecular weight polyethylene (UHMWPE) woven yarn, meeting ASTM F2848-17 requirements. The blue dye used is FDA approved.
How is the product sterilized?
The suture anchor system is EO (Ethylene Oxide) sterilized to ensure it is safe for immediate use in orthopedic surgery.
What is the intended clinical usage?
It is primarily used in orthopedic and sports medicine surgeries to connect soft tissue (such as tendons or ligaments) securely to the bone.
What is the warranty and shelf life?
The product comes with a 3-year warranty and is packaged in professional blister boxes to maintain its sterile integrity.
Are OEM services available for this system?
Yes, OEM services are available to meet specific clinical or regional requirements while maintaining CE and ISO certifications.

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