Julie A. Vetalice, Author at ORTHOWORLD

Safe Orthopaedics Enters Distribution Agreement Covering Australia and New Zealand

Safe Orthopaedics received regulatory approval in Australia for its SteriSpine product range, and entered into an agreement with SSJ Health covering regional distribution.

Apr 13, 2016

Strategic Orthopaedic-related 510(k)s issued in March 2016

Company Updates Competitive Landscape

Strategic orthopaedic-related 510(k)s issued in March 2016 include: Vantage Total Ankle (Exactech), Align Anterior Ankle Fusion Plate (Extremity Medical), Jazz Lock (Implanet), PROLIFT Expandable Interbody System (Life Spine), OrthAlign Plus UniAlign (OrthAlign), Tesera SC Standalone Anterior Cervical Plate (Renovis Surgical), S-Wire (Spinal Resources), Interbody System (Surgtech), Xspan Laminoplasty Fixation System (X-spine/Xtant Medical) (View the full list of orthopaedic 510(k)s for March 2016)

Apr 13, 2016

Tyber Medical Awarded State Funding

Investments The Numbers

Tyber Medical was awarded a US $362,500, ten-year loan from the Pennsylvania Industrial Development Authority to purchase equipment for in-house fabrication.

Apr 12, 2016

EOS imaging Receives FDA Clearance for spineEOS

ORTHOFLASH Robotics/Tech

EOS imaging received FDA clearance to market spineEOS, online 3D planning software for spine surgery based on stereo-radiographic 2D/3D imaging.

Apr 12, 2016

Centric Medical Launches TARSA-LINK StandAlone Wedge Fixation for Foot and Ankle

ORTHOFLASH Trauma

Centric Medical commenced full market release of TARSA-LINK™, a PEEK-based standalone wedge for internal fixation of fractures, fusions and osteotomies in the foot/ankle.

Apr 12, 2016

LISI Medical to Acquire Alcoa Remmele

Competitive Landscape Mergers & Acquisitions

LISI Medical, a contract manufacturer, signed an agreement to acquire Alcoa Remmele for 90MM (~US $102MM). The transaction is expected to close in 2Q16. Remmele posted 2015 revenue of $70MM.

Apr 12, 2016

Stryker Acquires SafeWire Portfolio for Minimally Invasive Spine Procedures

Competitive Landscape Mergers & Acquisitions

Stryker Spine acquired SafeWire’s product portfolio, including the Y-Wire guidewire and Tiger Jamshidi Needle for use in minimally invasive spine surgery.

Apr 11, 2016

RTI Surgical Launches Deformity Instrumentation for Streamline TL Spinal Fixation System

ORTHOFLASH Spine

RTI Surgical launched deformity instrumentation for the Streamline® TL Spinal Fixation system for treatment of complex adult deformities or curvatures in the thoracolumbar spine.

Apr 11, 2016

Bodycad Introduces Bodycad OnCall Custom Orthopaedic Restorations

Joint Replacement ORTHOFLASH

Bodycad introduced Bodycad OnCall™, personalized, individually-manufactured orthopaedic restorations for complex cases, particularly oncology, revision and osteotomy applications.

Apr 07, 2016

K2M MESA Mini and DENALI Mini Spinal Systems Receive Additional FDA Clearance in Posterior Cervical Spine

ORTHOFLASH Spine

K2M received FDA 510(k) clearance for expanded indications of its MESA® Mini and DENALI® Mini spinal systems for stabilization of the posterior cervical and thoracic spine as an adjunct to fusion.

Apr 06, 2016

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