SPINE-TECH BAK SPINAL FUSION IMPLANT SYSTEM IS APPROVABLE BUT NEEDS POSTMARKET STUDY TO ADDRESS LONG-TERM WEIGHT-BEARING CAPACITY, PANEL CONCLUDES
This article was originally published in The Gray Sheet
Executive Summary
Spine-Tech's BAK spinal fusion implant system is approvable as long as the firm conducts a five-year postmarket study and modifies proposed labeling, FDA's Orthopedic and Rehabilitation Devices Advisory Panel concluded in a 7-1 vote at a May 23 meeting in Gaithersburg, Maryland.