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Titanium Trauma Implant System

DGIMED ORTHO required a new titanium intra-medullary nail fixation device (IMFD) including a complete set of associated orthopedic instruments.

Devicix was engaged to create new orthopedic implants, and work with DIGIMED medical advisors to develop optimal orthopedic instruments.

Medical product design by Devicix:

Concept to 510k submission in 11 months
Class II medical device, FDA approved
Complete medical product design history file DHF
Orthopedic implant (nail) anatomical optimization
Detailed design of all orthopedic implants: nail, screws and end caps
Design of complete set of orthopedic instruments
Testing of orthopedic implants (nails and screws) per ASTM standards
Design verification of orthopedic products
Cadaver tests for design, instructions for use (IFU), and human factors engineering (HFE) validation

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