CE & ISO 13485 Certified Exporter

Humerus Interlocking Nails Factories & Exporters for Bulgaria

Precision-Engineered Titanium & Stainless Steel Intramedullary Humeral Nailing Systems Compliant with EU MDR Standards for Bulgarian Hospitals & Distributors

Catalog Overview

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Supplying Bulgaria’s leading trauma centers in Sofia, Plovdiv, Varna, and Burgas with high-precision orthopedic implants, intramedullary solutions, and specialized surgical sets.

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Industry Whitepaper Analysis

Biomechanical Superiority of Intramedullary Humeral Interlocking Nails

An authoritative evaluation of humeral shaft fracture management (AO/OTA Type 12), comparing rigid closed intramedullary nailing against traditional open reduction plate fixation in the Southeastern European clinical landscape.

Antegrade & Retrograde Dual Approach

Our specialized Humeron Interlocking System supports both proximal antegrade insertion via the rotator cuff seam and distal retrograde insertion through the olecranon fossa, minimizing soft tissue disruption and reducing radial nerve palsy risk.

EU MDR (2017/745) Harmonization

Fully compliant with European Union Medical Device Regulations. Certified under ISO 13485:2016, enabling seamless registration with the Bulgarian Executive Agency for Medicines (BDA) and direct participation in National Health Insurance Fund (NHIF) tenders.

Multi-Planar Locking Geometry

Distal dynamic compression slots combined with proximal multi-directional locking screw options prevent rotational instability and axial shear, ensuring non-union rates below 2.1% in complex non-comminuted fractures.

35+
Years of Manufacturing
50+
Global Markets Exported
2,000+
Precision Implant SKUs
100%
EU MDR & ISO 13485 Compliant
Technical Engineering

Metallurgical & Geometric Specifications

Manufactured in our state-of-the-art facility using high-precision Swiss CNC lathes and German milling centers, engineered for long-term load bearing and reduced stress shielding.

Specification Parameter Titanium Alloy Variant (Ti-6Al-4V ELI) Stainless Steel Variant (316LVM) Clinical Advantage for Surgeons
Standard Compliance ASTM F136 / ISO 5832-3 ASTM F138 / ISO 5832-1 Complete biocompatibility & corrosion resistance
Diameter Options (mm) 6.7mm, 7.5mm, 8.5mm, 9.5mm 7.0mm, 8.0mm, 9.0mm Precise reamed & unreamed canal fitment
Length Range (mm) 180mm – 320mm (20mm increments) 200mm – 320mm (20mm increments) Covers anatomical variations across Bulgarian demographics
Proximal Locking Holes 3 Multi-planar locking options 2 Static / Dynamic locking options Superior purchase in osteoporotic bone heads
Distal Locking Options 1 Dynamic Slot + 1 Static Hole 1 Dynamic Slot + 1 Static Hole Controlled post-operative dynamic compression
Surface Treatment Type II Anodization (Anti-galling) Electropolished Mirror Finish Prevents cold welding; easy extraction if required
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Bulgarian Market Integration

Clinical Applications in Bulgaria's Healthcare System

Adapting international trauma solutions to meet the specific requirements of Bulgarian municipal, university, and private emergency healthcare providers.

Sofia & Plovdiv Emergency Trauma Hubs

High-volume emergency hospitals such as University Emergency Hospital "N.I. Pirogov" in Sofia and St. George Hospital in Plovdiv demand rapid-dispatch intramedullary implants. Our Humeron nail system provides radiolucent insertion instruments that decrease operative time under fluoroscopy by up to 25%.

  • Minimized C-arm radiation exposure for surgical teams
  • Self-tapping locking screws eliminate tedious tapping steps
  • Universal left/right anatomical curvature for reduced SKU holding

Geriatric Traumatology & Osteoporosis Care

With Bulgaria experiencing a demographic shift toward an aging population, proximal humeral fractures accompanied by osteopenia present severe surgical challenges. Dual-angle proximal locking configurations allow secure fixations in compromised metaphyseal bone stock.

  • Ascending screw positioning supports the humeral head
  • Cannulated options facilitate smooth guide-wire tracking
  • Reduced disruption to periosteal blood supply speeds healing
Siora Surgicals ISO 13485 Manufacturing Facility
Manufacturing Infrastructure

Why Siora Surgicals is the Preferred OEM & Export Partner

Siora Surgicals Private Limited operates a modern, ISO 13485:2016-certified manufacturing complex in Sonipat, Haryana, India. Equipped with multi-axis CNC machines, automated passivating lines, and ISO Class 7 cleanrooms, we deliver world-class implants directly to Bulgarian medical distributors.

Private Label & OEM Services:

Custom laser etching of distributor branding, custom sterile packaging, and localized Bulgarian labeling compliant with EU regulations.

Robust Ready Stock Inventory:

Over 2,000 SKUs held in stock to ensure rapid export fulfillment within 7-10 business days via direct air cargo to Sofia (SOF).

Comprehensive Regulatory Dossiers:

Providing full Technical Files, Design History Files (DHF), biocompatibility reports (ISO 10993), and risk assessments (ISO 14971).

Frequently Asked Questions

Bulgarian Procurement & Clinical Technical FAQ

Addressing key questions from Bulgarian medical supply companies, orthopedic procurement officers, and surgical hospital boards.

? Are Siora’s Humerus Interlocking Nails fully certified for import and sales in Bulgaria?
Yes. All humerus interlocking nails, screws, and surgical instruments manufactured by Siora Surgicals hold CE certifications and are produced under ISO 13485:2016 quality management systems. They satisfy all requirements mandated by the Bulgarian Executive Agency for Medicines (BDA) and EU Medical Device Regulation (MDR 2017/745).
? What are the shipping timelines and delivery routes for orders to Sofia or Varna?
Standard inventory orders are processed and dispatched within 3 to 7 working days from our factory. We ship directly to Sofia International Airport (SOF) via air express courier (DHL/FedEx/Lufthansa Cargo) or via sea freight through the Port of Varna / Port of Burgas for heavy bulk container orders. Air shipment delivery typically takes 4-6 calendar days.
? Can Siora provide private labeling and custom box packaging for Bulgarian medical distributors?
Absolutely. We offer complete Contract Manufacturing and OEM / Private Labeling services. This includes custom laser-marking of your company logo on the nails and instrument trays, as well as customized outer box artwork with Bulgarian text (in Cyrillic) meeting national labeling norms.
? What materials are available for the Humerus Interlocking Nailing system?
We manufacture humerus interlocking nails in both Medical Grade Titanium Alloy (Ti-6Al-4V ELI conforming to ASTM F136) and Stainless Steel (316LVM conforming to ASTM F138). Titanium implants offer superior magnetic resonance imaging (MRI) compatibility and a lower modulus of elasticity closer to cortical bone, while Stainless Steel options offer cost-effective trauma solutions.
? How does Siora support Bulgarian public hospital tenders (NHIF / НЗОК)?
We supply distributor partners with complete technical documentation packages, declaration of conformity, clinical evaluation reports, ISO/CE certificates, and highly competitive direct factory wholesale pricing structure, enabling our partners to win municipal and national hospital tenders consistently.
Global Footprint

Exporting Orthopedic Excellence to 50+ Nations

Siora Surgicals has established a global reputation as a dependable manufacturer of trauma implants. Our products are routinely used by orthopedic surgeons across Eastern Europe, Western Europe, the Middle East, Latin America, and Asia-Pacific.

"Our mission is to engineer affordable, uncompromising orthopedic devices that restore patient mobility while empowering healthcare providers through seamless global supply chains."

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Siora Surgicals Global Export Distribution Map

Expand Your Orthopedic Portfolio in Bulgaria

Partner directly with Siora Surgicals — a premier manufacturer & exporter of CE-certified humerus interlocking nails, locking plates, spine systems, and arthroscopy solutions. Request technical specifications, sample kits, or wholesale tender quotations today.

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