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Interbody Fusion Device
A leading spine surgeon created a virtual company with private funding to develop his concept for a novel interbody fusion device. This medical product design required associated orthopedic instruments as well, including a novel delivery cannula.
Devicix was contracted to develop the concept into a working medical product design and obtain 510(k) premarket notification approval. The virtual company leveraged Devicix’s ISO 13485 and 14971 design controls, and their project management, mechanical engineering, biomedical engineering, and quality assurance services.
Medical product design by Devicix:
- Concept to 510k submission in 15 months
- Class II medical device, FDA approved
- Complete medical product design history file (DHF)
- Detail design of interbody fusion cage and orthopedic instruments
- Testing of orthopedic implants per ASTM standards
- Orthopedic product design verification
- Design, instructions for use (IFU), and human factors engineering (HFE) validation
