As a premier OEM/ODM manufacturer of Pedicle Screw Systems, our commitment extends beyond fabrication into the realm of clinical efficacy and patient-centric design. In an era of increasing spinal degeneration cases globally, our technical roadmap focuses on biocompatible titanium alloys and polyaxial screw mechanics that provide surgeons with unmatched intraoperative flexibility.
We leverage advanced CNC precision machining to ensure every thread pitch and screw head tolerance meets rigorous ISO 13485 standards. Our R&D team continuously integrates Information Gain into our manufacturing process by analyzing post-operative data to refine mechanical stability and reduce bone-screw interface micro-motion.
Operating a medical facility demands strict adherence to global regulatory landscapes, including FDA and CE marking requirements. Our local support teams assist global procurement partners in navigating localization challenges and regulatory submissions. We don't just supply components; we provide an ecosystem of quality assurance that minimizes your time-to-market.
State-of-the-Art Factory
Advanced Production Lines
Exporting Countries
Expert Engineering Team
Q: What is your capability for OEM/ODM customization?
A: We offer full-cycle customization from initial CAD modeling to mass production, strictly following clinical requirements for spinal implants.
Q: How do you ensure product quality and safety?
A: Our facility operates under ISO 13485 protocols, with rigorous material inspection and 100% functional testing for all pedicle screw systems.
Q: Can you support global regulatory compliance?
A: Yes, we provide comprehensive technical documentation and assist our partners with local registration processes.
Pure Orthopedic Implants
