Small Bone Innovations, Inc. Receives US FDA 510(k) Clearance for Mini-Rail Fixation System and Large Cannulated Screw System
Supports and enhances expansion of lower limb continuum of care product portfolio
Innovative instrumentation and versatility may reduce OR time
NEW YORK–(HSMN NewsFeed)–Small Bone Innovations, Inc. (SBi), a leading, privately-held orthopedics company focused exclusively on technologies and treatments for the small bones & joints, announced that it has received 510(k) pre-market clearance notifications from the U.S. Food and Drug Administration (FDA) for Mini-Rail Fixation System (‘Mini-Rail System’) and large Cannulated Screw System for use in lower limb reconstruction and repair procedures. (more…)
CARLSBAD, Calif., Feb. 2, 2010 — (HSMN NewsFeed) — Alphatec Holdings, Inc. (Nasdaq:ATEC ), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, today announced that the Company has received the CE Mark for commercial sale in the European Union and other jurisdictions for its OsseoScrew Spinal Fixation System and its Guided Lumbar Interbody Fusion (GLIF) System / Arc Portal System. The receipt of the CE Mark allows Alphatec Spine to begin selling these implants in the European Union and certain other jurisdictions that recognize the CE Mark for commercial approval. 
ST. PAUL, Minn. – (Business Wire) Spineology Inc., developer and manufacturer of minimally invasive spinal surgery devices, announced today that it has received FDA clearance for its minimally invasive surgery (MIS) Capture™ Facet Screw System. 