S33 SPINE

S33 SPINE Spinal Implants Manufacturer | Spine Surgery Instrumentation

🎯 Posterior Cervical Pedicular Screws📍 S33 Spine Posterior Cervical System offers multiple screws, hooks, rods with hexa...
20/05/2024

🎯 Posterior Cervical Pedicular Screws

📍 S33 Spine Posterior Cervical System offers multiple screws, hooks, rods with hexagonal tips, transition rods, occipital plates and different type of connectors for a better match patient anatomy.

📍 Friction head screw feature
📍 Five points of fixation on the occipital plate
📍 Self-tapping Screws for a proper and safe placement and are available in 3.5 mm & 4.0 mm diameters

⚡ Anterior Cervical Disc Prosthesis⚡ MOTION PRESERVATION
29/02/2024

⚡ Anterior Cervical Disc Prosthesis
⚡ MOTION PRESERVATION

  📢 We are at process of transitioning to MDR. EU Medical Devices Regulation 2017/745 - MDR​  (2017/745) is a regulation...
25/09/2023



📢 We are at process of transitioning to MDR.

EU Medical Devices Regulation 2017/745 - MDR

(2017/745) is a regulation on clinical research and sale of medical devices.

The purpose of this regulation is to determine the procedures and principles regarding the protection of the health of patients, users, and other persons, as well as ensuring high quality and safety standards in medical devices.

As it is known, the Medical Device Regulation (MDR) No. 2017/745 (EU) entered into force by being published in the EU Official Journal Gazette on 25 May 2017. It was foreseen to be implemented by 26 May 2020, but due to the coronavirus pandemic, the date of implementation and the repeal date of the current directives (MDD) have been updated to 26 May 2021.

Spine maintains a “sustainable quality understanding" for all our staff in terms of preparations for MDR process. In order to fulfill the new obligations of MDR, we try to combine "teamwork" and "quality awareness" to ensure the safety of our products.


🌟 Quality Management📌 ISO 13485:2016 Quality Management System is efficiently adapted on the organization of S33 Spine a...
22/09/2023

🌟 Quality Management

📌 ISO 13485:2016 Quality Management System is efficiently adapted on the organization of S33 Spine and provides a 100% traceability from raw material to final product.

Our main task with respect to Quality Management is ensuring a complete control in a reliable and continuous production quality with machining, polishing, washing, color anodizing and laser marking units within our organization.

​Biomechanical and biocompatibility tests were performed in accordance with ASTM and ISO standards which are required to launch our products to the market reliably.

Our claim is to consistently develop our products, to keep our quality at the highest level, to ensure requirements of quality management procedures considering countries’ regulatory systems.

We also strive to provide requirements of the MDR(2017/745/ EU) which is the new regulation for medical device companies to sell their products in Europe as well as other countries.

S33 SPINE - SPINAL IMPLANTS CATALOGUE: https://www.s33spine.com/resources

:2016

14/09/2023

📌 About Us

S33 Spine which has been developed based on our spinal implants manufacturing and brand-management background with a years of experience is a sub brand under Prodorth umbrella. The products of S33 Spine are manufactured with perfection to match our high quality standards. We developed alternative solutions to offer affordable prices by data transfers from Prodorth’s infrastructure such as technical files, technical drawings, established workmanship organization, ads design etc. Teamwork, enthusiasm and dedication are crucial for the sustainable success of S33 Spine. We guarantee added value for our users and clear competitive benefits for our distributors.

RD Medikal is the name of the company where commercial brand names Prodorth and S33 Spine products are produced. It was founded in 2013 by Mechanical & Materials Engineers, as well as the contribution of the healthcare professionals.

Within our journey, we always tried to follow up the latest technologies by combining them with the user-friendly approaches which are the accepted and well-known methods by surgeons.

We always try to provide the most simple instrumentation not only to carry out the surgical procedures simply but also to obtain the most efficient solutions and to provide patients and surgeons with our progressive spinal medical devices with RD MEDİKAL’s high-tech production lines.

Elevating Your Experience: Our Commitment to Customer Satisfaction! 🌟S33 SPINE, our mission has always been to create an...
11/08/2023

Elevating Your Experience: Our Commitment to Customer Satisfaction! 🌟
S33 SPINE, our mission has always been to create an exceptional journey for our valued customers. We understand that your satisfaction is the fundamentals of our success, and we're thrilled to share how we're taking your experience to new heights!

👂 We Listen: Your feedback accelerates our progress! We have dedicated ourselves to actively listening to your thoughts, suggestions, and concerns. Your voice shapes our decisions, and we're grateful for the trust you place in us to deliver on your expectations.

Anterior Cervical Disc ProsthesisMOTION PRESERVATION
20/07/2023

Anterior Cervical Disc Prosthesis
MOTION PRESERVATION

S33 SpineSpinal Implants & Instrumentation•Biocompatible•It does not cause any lesional problems•Has elastic and hardnes...
19/06/2023

S33 Spine

Spinal Implants & Instrumentation
•Biocompatible

•It does not cause any lesional problems

•Has elastic and hardness features near bone tissue

•Titanium alloy materials give an opaque image under

X-Ray, besides PEEK materials, is able to be viewed transparently. This provides a more efficient follow-up for bone fusion through the implant material during postoperative period

If you look at the spine from the back, it normally runs straight from the head to the pelvis. With scoliosis, however, ...
01/06/2023

If you look at the spine from the back, it normally runs straight from the head to the pelvis. With scoliosis, however, there are one or more curves with the spine curving to the side and in some cases, it is twisted on itself. This reduces mobility. Why such a curve develops in children is not known in many cases. In adults, scoliosis is caused by the degeneration of the discs. Mild scoliosis is often not noticed at all. If the curve increases, however, the shoulders and pelvis appear crooked. A pronounced curve to the side stresses the spine and can lead to signs of wear and therefore to back pain.

. Early detection provides better outcomes. Additionally, can have negative effects on mental health. The goal is to spotlight the growing need for education, early detection, and awareness to the general public about and its common presence within the community.

05/04/2023

Products & Spinal Implants & Raw Materials
Product Specifications

Material selection is one of the most important point for implants.
Titanium Alloy (Ti6Al4V-ELI Grade 23 / ISO 5832-3 / ASTM F136) and PEEK (Polyether-ether-ketone / ASTM F2026) are used as raw materials for all S33 Spine products and these are all originated from EU and USA. Both material are biocompatible and adequate for long term use (C = Permanent (> 30 days)).

PEEK material is a remarkable raw material with its unique properties;

​•Biocompatible
•It does not cause any lesional problems
•Has elastical and hardness features near to bone tissue
•Titanium alloy materials give an opaque image under X-Ray, besides PEEK materials is able to be viewed transparently. This provides a more efficient follow-up for the bone fusion through the implant material at post-operative period

https://www.s33spine.com/spinal-implants-instrumentation

Products & Spinal Implants & Raw MaterialsProduct SpecificationsMaterial selection is one of the most important point fo...
28/03/2023

Products & Spinal Implants & Raw Materials
Product Specifications
Material selection is one of the most important point for implants.
Titanium Alloy (Ti6Al4V-ELI Grade 23 / ISO 5832-3 / ASTM F136) and PEEK (Polyether-ether-ketone / ASTM F2026) are used as raw materials for all S33 Spine products and these are all originated from EU and USA. Both material are biocompatible and adequate for long term use (C = Permanent (> 30 days)).

PEEK material is a remarkable raw material with its unique properties;

​•Biocompatible
•It does not cause any lesional problems
•Has elastical and hardness features near to bone tissue
•Titanium alloy materials give an opaque image under
X-Ray, besides PEEK materials is able to be viewed transparently. This provides a more efficient follow-up for the bone fusion through the implant material at post-operative period

https://www.s33spine.com/spinal-surgery-instrumentationExperiences and recent researches show the success of instruments...
28/03/2023

https://www.s33spine.com/spinal-surgery-instrumentation

Experiences and recent researches show the success of instruments directly effects the success of surgeries. Implants and instruments should be considered together for better solutions. Therefore, S33 Spine designs and manufactures user friendly and high quality instruments in order to obtain the best results. Made of special stainless steel raw material with ultra high corrosion resistance and silicone appropriate for medical applications.

Besides the high corrosion resistance, they are also appropriate for all kind of sterilization types including steam sterilization at high temperatures. (Up to 137° degree)

Critical instruments such as screw drivers, nut drivers are offered double pieces in the container in case of any failure or falling on the floor. Hence the surgeon will be able to continue surgery without wasting time.

Special designed rod cutters provides less burrs and esaier cutting are available on request.

Entire items of S33 Spine Instrumentation are CE certified. We offer completely suitable instruments for degenerative, as well as deformity cases. It’s possible to add or exclude the required instruments according to our customers’ needs.

Address

RD Medikal Tıbbi Ürünler San. Tic. A. Ş Karacaoğlan Mah. Bornova Caddesi No:9/G/1 Bornova IZMIR TURKEY
Izmir
35070

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