Theradaptive receives FDA breakthrough device designation for spinal fusion implant
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Theradaptive has announced FDA breakthrough medical device designation for its Osteo-Adapt SP spinal fusion implant for use in transforaminal lumbar interbody procedures, according to a press release.
The Osteo-Adapt SP implant is a regenerative implant indicated for patients with degenerative disc disease, spondylolisthesis or retrolisthesis who are undergoing transforaminal lumbar interbody spinal fusion, according to the release.
“This designation is a major milestone for Theradaptive as we aspire to change the practice of medicine by enabling precise tissue regeneration in a way that was not previously possible,” John Greenbaum, senior vice president of clinical and regulatory operations at Theradaptive, said in the release. “This opens the door to entirely new treatments for conditions that currently have few options,” Greenbaum added.
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