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S33 SPINE CATALOGUE

S33 SPINE CATALOGUE
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S33 SPINE CATALOGUE

Product catalog summary
About Us
S33 Spine, a sub-brand of Prodorth, focuses on spinal implants and instrumentation, offering high-quality and affordable solutions. RD Medikal, established in 2013, manufactures these products using advanced technologies and user-friendly designs.

Mission and Vision
The company aims to deliver innovative solutions that meet customer needs, emphasizing research and development to enter new markets. Their vision is to improve patient lives and provide preferred products and services to surgeons.

Quality Management
S33 Spine complies with the ISO 13485:2016 Quality Management System, ensuring traceability from raw materials to final products. They conduct biomechanical and biocompatibility tests according to ASTM and ISO standards and adhere to MDR (2017/745/EU) regulations.

Research & Development
The R&D process involves design transfer to production, quality control, and customer feedback integration, ensuring supplier and raw material conformity.

Certificates
S33 Spine holds ISO 13485:2016 certification for implants and instruments, ensuring high-quality standards and international compliance.

Customer Satisfaction
The company values long-term customer relationships and provides excellent after-sale services, considering high quality a standard.

Distributorship
RD Medikal, based in Izmir, Turkey, manufactures spinal implants and instruments under the S33 Spine brand, offering competitive prices without compromising quality.

Product Specifications
S33 Spine uses Titanium Alloy (Ti6Al4V-ELI Grade 23) and PEEK as raw materials, both biocompatible and suitable for long-term use. PEEK's transparency under X-ray aids post-operative follow-up.

Anterior Cervical Products
  • PEEK Cages & Bladed: Designed for easy application, these cages prevent migration and offer enhanced hold with blades.
  • Disc Prosthesis: Made of titanium and PEEK, these prostheses preserve motion and offer a wide range of motion.
  • PEEK Cage with Screws: Provides stability with screws, eliminating the need for an anterior plate.
  • Plate System: Offers a variety of plates and screws, designed for easy implantation and high pull-out strength.


Posterior Cervical Products
  • Pedicular Screws: Feature friction head screws and a wide range of angulation for better anatomical match.
  • Occipital Plate and Spinal Connectors: Designed for secure fixation and easy identification with color-coded implants.


Posterior Fixation Systems
S33 Spine's pedicular screws have a unique design for long-term stability and are subject to strict quality control. They offer a wide range of options to meet various patient pathologies.
Specifications:
The document details spinal implant components, including polyaxial and monoaxial screws, cannulated pedicular screws, spinal connectors, and spinal rods. Screws range from Ø3.5 to Ø8 mm in diameter and 25 to 120 mm in length. Spinal connectors include multiaxial, linear, bar type, and domino connectors, with specified sizes. Spinal rods are made from Ti6Al4V-ELI Grade 23 material.

Procedures:
The S33 Spine Fenestrated Screw System is designed for osteoporotic pathologies, fractures, and osteotomies, featuring a cement injectable design. TLIF and PLIF PEEK cages are used for lumbar fusion, with specific implantation and positioning procedures. The cages combine PEEK and titanium alloy, offering radiolucent imaging and anatomical design.

Norms and Standards:
Materials like Ti6Al4V-ELI Grade 23 and PEEK comply with ASTM and ISO standards, ensuring quality and compatibility with vertebral bodies.

Recommendations:
The document recommends using the S33 Spine Surgery Kit, which includes various instrumentation sets for different spinal surgery procedures, such as posterior fixation, lumbar fusion, and anterior cervical plate systems.

Key Data from Tables and Figures:
The document provides detailed specifications for each component, including sizes and materials, ensuring that the implants meet specific surgical needs and standards.
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Catalog excerpts

S33 SPINE CATALOGUE-1

SPINAL IMPLANTS & INSTRUMENTATION

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S33 SPINE CATALOGUE-3

About Us Quality Management Certificates Customer Satisfaction Distributorship Raw Materials Anterior Cervical Posterior Cervical Posterior Fixation Systems Lumbar Fusion Spinal Surgery Instrumentation Contact

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S33 SPINE CATALOGUE-4

| Spinal Implants & Spinal Surgery Instrumentation 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...

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S33 SPINE CATALOGUE-5

| Spinal Implants & Spinal Surgery Instrumentation Spinal Implants & Spinal Surgery Instrumentation

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S33 SPINE CATALOGUE-6

| Spinal Implants & Spinal Surgery Instrumentation 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, ultrasonic 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...

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S33 SPINE CATALOGUE-7

| Spinal Implants & Spinal Surgery Instrumentation Research & Development Transfer of design to productıon Customer Feedbacks Compliance, Regulations QUALITY MANAGEMENT STORAGE & LOJISTIC Packing control Final quality control PRODUCTION Machining, Cleaning, Anodizing, Laser marking control PURCHASING Conformity of suppliers Conformity of raw materials

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S33 SPINE CATALOGUE-8

PRD+ TRADEMTRK PRODORTH TRADEMARK | Spinal Implants & Spinal Surgery Instrumentation 6

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S33 SPINE CATALOGUE-9

| Spinal Implants & Spinal Surgery Instrumentation Customer Satisfaction The company takes part in the biomedical industry with its innovative and high quality products. S33 Spine products are designed, manufactured and developed in our organization, and the results are always met with the approval of well-known surgeons. S33 Spine began its journey with the principle of “Human First” and always proceed in this way. Knowledge combined with technology and innovator approach... “Customer Satisfaction” is not just a catchphrase for us as we aim at maintaining long-term relationships with our customers....

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S33 SPINE CATALOGUE-10

| Spinal Implants & Spinal Surgery Instrumentation

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S33 SPINE CATALOGUE-11

| Spinal Implants & Spinal Surgery Instrumentation

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S33 SPINE CATALOGUE-12

| Spinal Implants & Spinal Surgery Instrumentation High Quality Production SPINAL FIXATION SYSTEMS SMETSYS NOITAXIF LANIPS Customer Satisfaction Wide Product Range Certification & Regulatory

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S33 SPINE CATALOGUE-13

| Spinal Implants & Spinal Surgery Instrumentation Distributorship For expanding or improving our sales force, we reach patients and surgeons with our gained experiences all around the world through our distributors since 2013. RD MEDIKAL is a company located in Izmir, Turkey, manufactures Spinal Implants & Instruments under our registered brand “S33 Spine” with competitive prices without compromising of the quality of our products. Our primary goal is reaching innovative solutions by simple approaches which earned us a reputation within the spinal implants field

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S33 SPINE CATALOGUE-14

| Spinal Implants & Spinal Surgery Instrumentation 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...

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S33 SPINE CATALOGUE-15

| Spinal Implants & Spinal Surgery Instrumentation

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S33 SPINE CATALOGUE-16

| Spinal Implants & Spinal Surgery Instrumentation Anterior Cervical PEEK Cages & Bladed S33 Spine Cervical PEEK Cages provide a great hold on to the endplates with its blade, which allows it to be used without a plate. One of the best advantage of S33 Spine Cervical Peek Cages is offering a very simple application which is found user-friendly by surgeons. S33 Spine Cervical Peek Cages with mono / double blade options and regular cervical peek cages are available on request. • Toothed surface is designed to prevent migration • As for the bladed options, blades provides a more reliable hold on...

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S33 SPINE CATALOGUE-17

| Spinal Implants & Spinal Surgery Instrumentation Anterior Cervical Disc Prosthesis It is an alternative to the commonly performed anterior cervical discectomy and fusion (ACDF), a surgical procedure that is designed to address the pathology by eliminating motion at the diseased disc level. Artificial disc replacement (ADR) surgery—also known as a total disc arthroplasty or total disc replacement (TDR)—is typically performed for a patient with a cervical disc herniation that is causing significant neck pain and/or arm pain that has not responded to nonsurgical treatment options and is significantly...

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S33 SPINE CATALOGUE-18

| Spinal Implants & Spinal Surgery Instrumentation Anterior Cervical PEEK Cage with Screws S33 Spine Stand-Alone Cervical PEEK Cage System provides an improved stability with the screws on it. The system offers an interbody fusion device with screw fixation and is intended to be used in ACDF procedures. S33 Spine PEEK cage with titanium screws and locking mechanism provides a stable fixation without the need of an anterior plate. S33 Spine Stand-Alone Cervical PEEK Cage System keeps the cervical spine’s natural sagittal anatomic profile while providing anterior column support and contribution...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.