Joline® receives FDA approval for kyphoplasty products
June 30, 2020. Joline GmbH & Co. KG announces that the company has obtained FDA approval from the U.S. Food and Drug Administration (FDA) for Joline® Kyphoplasty products to treat vertebral compression fractures.
The Joline® Kyphoplasty System Allevo is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).
510(k) No. K192449
OMB No. 0910-0120