This CE & ISO 13485 certified maxillofacial orthopedic set is a professional surgical solution specially designed for maxillofacial surgery, orthognathic surgery, mandible reconstruction, and neurosurgery. The complete set includes titanium mini implant plates, matching screws, and specialized surgical instruments, all stored in a high-temperature resistant autoclavable sterilization box.
Key Features & Benefits
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Medical Grade Material: Premium Stainless Steel and Aluminum Alloy for maximum durability and corrosion resistance.
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Precision Machined: Perfect anatomical fit for maxillofacial structures, ensuring fixation accuracy.
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Complete Integration: Includes mini plates, screws, and matching specialized instruments in one set.
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Advanced Sterilization: High-temperature resistant autoclavable box for reliable sterile management.
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Global Standards: Fully compliant with CE and ISO 13485 medical device regulations.
Packaging & Certification
Frequently Asked Questions
1. What components are included in this complete instrument kit?
The set includes maxillofacial titanium mesh mini plates, matching implant screws, specialized surgical instruments for fixation, and a high-temperature resistant autoclavable sterilization box.
2. Are the materials used compliant with medical implant standards?
Yes, the mini plates are made of medical-grade titanium for biocompatibility. Instruments and the sterilization box are crafted from medical-grade stainless steel and aluminum alloy, all CE and ISO 13485 certified.
3. Which surgical scenarios is this set designed for?
It is ideal for mandible reconstruction, orthognathic surgery, internal fixation of maxillofacial fractures, neurosurgery craniotomy fixation, and facial plastic reconstructive surgeries.
4. Can the instrument box be sterilized in an autoclave?
Absolutely. The aluminum alloy sterilization box is designed to withstand high-pressure steam sterilization at 134°C, meeting hospital operating room standards.
5. Do you support separate procurement for specific parts?
Yes, we support the purchase of the full set or individual components like specific plates, screws, or single surgical instruments based on your clinical requirements.
6. Is OEM customization available for branding?
We offer full OEM/ODM services, including laser engraving of logos on instruments and boxes, customized plate specifications, and tailored branded packaging.
DTRX Orthopedic Implants
