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Spine-Tech's BAK spinal fusion implant system is approvable, FDA tells firm June 20.

This article was originally published in The Gray Sheet

Executive Summary

SPINE-TECH BAK IMPLANT 200-PATIENT POSTMARKET STUDY is required as a condition of approval in FDA's June 20 approvable letter on the device, the company says. The approvable letter calls for eight-year follow-up data on 100 patients who have undergone posterior implantation with the device and 100 patients who have undergone an anterior implantation procedure. The firm says that it already has followed about 280 patients for three years post-surgery.
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