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RSSCategory: CE & FDA

Soteira Inc., Obtains 510(k) Clearance for Shield Kyphoplasty System

Akillas | December 14, 2011
Soteira Inc., Obtains 510(k) Clearance for Shield Kyphoplasty System

NATICK, Mass.–(Healthcare Sales & Marketing Network)– Soteira Inc., today announced the 510(k) clearance of the Shield Kyphoplasty System. Soteira Inc. President and CEO, Larry Jasinski, stated “The Shield Kyphoplasty System includes a unilateral, steerable cavity creator and a self expanding stent-like implant designed to direct PMMA cement flow for optimal placement during vertebral augmentation. This [...]

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X-spine Announces FDA Clearance of New Spinal Implant System for Treatment of Disk Disease

Akillas | December 9, 2011
X-spine Announces FDA Clearance of New Spinal Implant System for Treatment of Disk Disease

MIAMISBURG, Ohio–(Healthcare Sales & Marketing Network)– X-spine, an emerging leader in the design of devices for the treatment of spine disease, today announced FDA clearance of the AXLE™-PEEK Interspinous Fusion System. The AXLE-PEEK system consists of spinal implants FDA-cleared for the treatment of degenerative disk disease (DDD). The system expands on X-spine’s AXLE™ line of [...]

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LDR Announces FDA Clearance of the ROI-A Oblique ALIF Cage

Akillas | November 3, 2011
LDR Announces FDA Clearance of the ROI-A Oblique ALIF Cage

The first stand-alone oblique ALIF system in the US market features innovative VerteBRIDGE® plating technology and a specially-designed cage for simple insertion and stable fixation. Join the forum discussion on this post

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Spinal USA Gets FDA Approval for Two New Spinal Treatment Products

Akillas | October 29, 2011
Spinal USA Gets FDA Approval for Two New Spinal Treatment Products

PEARL, Miss.–(Healthcare Sales & Marketing Network)– Spinal USA, LLC announced today that it will introduce two new additions to the company’s portfolio of spinal treatment solutions at this year’s meeting of the North American Spine Society (NASS) in Chicago, IL, November 1-5. Join the forum discussion on this post

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