It is delighted to announce that ZATH’s full product line has gained CE approval. The products include:
1. Sterile hip prosthesis - Class III
2. Sterile/nonsterile Metal Bone Screw - Class IIb
3. Sterile/nonsterile Spinal Internal Fixation System - Class IIb
4. Sterile/nonsterile Locking Plate System - Class IIb
5. Sterile/nonsterile Cannulated Screw - Class IIb
6. Sterile/nonsterile Interbody Fusion Cage - Class IIb
7. Sterile/nonsterile External Fixation Frame (with pin) - Class IIb、
The approval of CE indicates that ZATH’s full product line complies with relevant standards and regulations of EU, and pave the way to enter European market and other regions in the world as well.
The product portfolio approved contains ZATH trauma (locking plate, bone screw, cannulated screw and external fixators), spine (spinal internal fixation and fusion systems) and joint replacement (hip joint) systems. At the same time, in addition to joint products, ZATH's trauma and spine products are also available in sterilized packaging, which can not only reduce the infection rate for patients, but also improve the inventory turnover rate of our distributor partners. At present, ZATH is the only orthopaedic manufacturer in the world that provides sterilized packaging for its entire product line.
One-time passing of CE certificate for the full product line not only represents ZATH’s strong technical strength and excellent quality, but also lays a solid foundation for taking further steps in the international market.
Through the development of over 10 years, ZATH has established the cooperation relationship in dozens of countries from European, Asian, African and Latin American regions. No matter from trauma and spine products, or joint replacement products, all ZATH products gain the high recognition from its international partners and surgeons all over the world.
With the approval of CE, we will take this opportunity to embark on a new journey in the orthopedic field worldwide.
Post time: Aug-29-2022