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SPINAL IMPLANTS & INSTRUMENTATION

SPINAL IMPLANTS & INSTRUMENTATION
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SPINAL IMPLANTS & INSTRUMENTATION

Product catalog summary
About Us
S33 Spine, a sub-brand of Prodorth, specializes in spinal implants and instrumentation, focusing on high-quality and affordable solutions. RD Medikal, established in 2013, manufactures these products with an emphasis on user-friendly and innovative approaches.
Quality Management
The company complies with ISO 13485:2016 standards, ensuring product traceability and adherence to ASTM and ISO standards for biomechanical and biocompatibility tests. It also aligns with MDR (2017/745/EU) regulations for medical devices.
Research & Development
Focuses on design transfer to production, quality control, and customer feedback, involving processes like machining, cleaning, anodizing, and laser marking.
Certificates
The company holds CE and ISO 13485:2016 certifications, emphasizing customer satisfaction and high-quality standards.
Distributorship
Based in Izmir, Turkey, RD Medikal distributes globally, offering competitive prices without compromising quality, aiming to expand market presence through innovation.
Product Specifications
Materials include Titanium Alloy (Ti6Al4V-ELI Grade 23) and PEEK, both biocompatible and suitable for long-term use. PEEK is transparent under X-ray, aiding post-operative follow-up.
Anterior Cervical Products
  • PEEK Cages & Bladed: Designed for easy application, preventing migration and offering enhanced hold with blades.
  • PEEK Cage with Screws: Provides stability with screw fixation, maintaining the cervical spine's natural profile.
  • Disc Prosthesis: Offers motion preservation with titanium and PEEK materials.
  • Plate System: Features low-profile plates and various screw sizes for anterior cervical surgery.
Posterior Cervical Products
  • Pedicular Screws: Offer wide angulation, made from titanium for strength and stability.
  • Occipital Plate, Spinal Connectors, and Rods: Designed for anatomical compatibility, offering various sizes and configurations.
Posterior Fixation Systems
Pedicular screws feature V-shaped threads for stability, available in mono and double-threaded options, integratable with posterior cervical systems, offering a wide range of components for diverse patient needs.
Specifications
  • Monoaxial and Polyaxial Screws: Diameters Ø3.5 to 8 mm, lengths 25 to 120 mm for monoaxial, and Ø4.5 to 7.5 mm, lengths 25 to 80 mm for polyaxial screws.
  • Cannulated Pedicular Screws: Diameters Ø5-7.5 mm, lengths 30-80 mm.
  • Spinal Connectors: Includes multiaxial, linear, bar type, and domino connectors with various size options.
  • Spinal Rods: Made from Ti6Al4V-ELI Grade 23, available in sizes Ø3.5x100 to Ø5.5x250 mm.
Procedures and Systems
  • S33 Spine Fenestrated Screw System: Designed for osteoporotic pathologies, fractures, and osteotomies, featuring a cement injectable design.
  • TLIF and PLIF PEEK Cages: Used for lumbar fusion, made from PEEK and titanium alloy, designed to minimize migration risk and provide radiolucent imaging.
  • Expandable PLIF PEEK Cage: Features a stopping system to prevent over-expansion, with enhanced cage-inserter connection.
Instrumentation
  • S33 Spine Surgery Kit: Includes various instrumentation sets for posterior fixation, lumbar fusion, anterior cervical, and deformity derotation systems.
Materials
The components are primarily made from titanium alloy (Ti6Al4V-ELI Grade 23) and PEEK, ensuring compatibility and durability in surgical applications.
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Catalog excerpts

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SPINAL IMPLANTS & INSTRUMENTATION

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

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

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| 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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| Spinal Implants & Spinal Surgery Instrumentation

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| Spinal Implants & Spinal Surgery Instrumentation

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

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| Spinal Implants & Spinal Surgery Instrumentation EXCELLENCE BEGINS HERE. GROW WITH US. 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...

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| 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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| Spinal Implants & Spinal Surgery Instrumentation

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| 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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| 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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| 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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*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.