SpiTrex CTE
+1 574-935-9611
2121 Walter Glaub Dr.
Plymouth, IN 46563
SpiTrex CTE Process
Quality-Driven from Concept to Completion
At SpiTrex CTE, our process is built on decades of orthopedic manufacturing experience, advanced engineering and an unwavering commitment to quality. Every project we take on follows a proven, tightly controlled workflow designed to deliver top-tier results, on time and to customer satisfaction.
As part of the SpiTrex Group, we combine CNC machining expertise with advanced technologies and a collaborative mindset that empowers our customers to bring life-changing devices to market with confidence. From early design input through product delivery, we integrate engineering, manufacturing and quality assurance under one roof.
Engineering Expertise
Our engineering team is the foundation of our process. With over 100 years of combined experience in medical device manufacturing, our experts bring a deep understanding of design, development and regulatory compliance to every project. We partner closely with customers to co-design high-performance, manufacturable solutions, and each product is optimized before it hits the production floor.
We leverage cutting-edge technologies, advanced prototyping and best-in-class software tools to further development while maintaining the highest standards of performance and quality.
Measured. Verified. Trusted.
At SpiTrex CTE, we employ automated measurement systems and real-time SPC data capture through MeasurLink to monitor part quality throughout production. Our Coordinate Measuring Machines and Vision Systems deliver highly accurate inspections of even the most complex geometries, helping every component we produce meet tight tolerances and critical specifications.
- ISO 13485:2016 certification
- FDA registration and full regulatory compliance
- Validated cleaning systems and equipment
- First Article Inspections on all new parts
- Critical-to-Quality tracking for each batch