WebOct 21, 2010 · Kyphon Xpander II IBT is the latest product from the creator of balloon kyphoplasty and maker of the Kyphon Xpander IBT. The new IBT is designed to have an improved, pre-determined inflation pattern1 and exert greater lifting force than that of the Kyphon Xpander IBT, Medtronic said. WebJun 30, 2011 · The Kyphon Xpander II IBT has been in physician preference testing since November 2010 in more than 180 cases throughout the United States. Vertebral compression fractures are the most common osteoporotic fractures with an estimated 900,000i spinal fractures occurring in the U.S. every year. These fractures have shown to …
510(k) Premarket Notification - Food and Drug Administration
WebKyphon™ inflatable bone tamps (IBT), or orthopaedic balloons, are available for use with 8 and 10ga introducers in three lengths — 10mm, 15mm, and 20mm — to address differing … KYPHON™ BALLOON KYPHOPLASTY PLATFORM Minimally Invasive Vertebral … WebMay 19, 2024 · The Kyphon Assist Directional Cannula is compatible across the Medtronic portfolio of balloon kyphoplasty products, including the Kyphon Xpander™ II Inflatable Bone Tamps. It provides the ... greg hedge fund stanford michigan
Kyphon® Xpander II - YouTube
WebMar 20, 2024 · Device Classification Name: arthroscope: 510(k) Number: K041454: Device Name: KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A: Applicant WebKYPHON® Inflation Syringe (1) GMDN Term Instrument tray, reusable (26) Inflatable bone tamp (9) Catheter/overtube balloon inflator, single-use (1) FDA Product Code Name TAMP (36) FDA Product Code HXG (36) Device Packaged As … WebSep 17, 2014 · The KYPHON Xpander(TM) II Inflatable Bone Tamps and KYPHON Express(TM) II Inflatable Bone Tamps are intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is … greg heckley attorney