Soteira Inc., Obtains 510(k) Clearance for Shield Kyphoplasty System
The Shield Kyphoplasty System 510(k) clearance was supported with extensive laboratory, animal, cadaver and clinical testing which included a Level 2 (Pilot Trial) and a Level 1 (Randomized Controlled Trial.)
Soteira Inc. is a Privately held venture-backed medical device company that engages in the development and commercialization of products used in osteoporotic bone repair. Osteoporotic vertebral compression fractures are a significant issue to the aging population which is continuing to expand, illustrated by the forecast of 200,000 compression fracture interventions in the US expected in 2012. (iData Research.)
Soteira can be contacted at 508-651-2611, x106 or via the company website: www.soteira.com.
Posted by Sean Fenske, Editor-in-Chief, MDT