A new flexible fixation device for the lumbar spine has been developed. This paper describes the development and evaluation of two surgical instruments required for implanting this device. Prototypes were designed, manufactured and then evaluated for use in surgery. Further evaluation was performed, if necessary, and the design finalized, in accordance with BS EN 12011. This process involved close collaboration between engineers and surgeons.
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Leahy et al. (2000) studied this question.
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