3Spine Inc. has announced FDA investigational device exemption approval for a clinical trial on the BalancedBack, a total joint replacement for the lumbar spine, according to a press release.
The BalancedBack total joint replacement is indicated for reconstruction and stabilization of a spinal motion segment following decompression for skeletally mature patients with symptomatic lumbar degeneration, according to the release.
“Breakthrough device designation was critical to our success in the investigational device exemption (IDE) approval process,” Ron Yarbrough, chief operating