Julie A. Vetalice, Author at ORTHOWORLD

Precision Spine Launches Reform Modular and HA-Coated Pedicle Screw Systems

Precision Spine launched its Reform Modular and HA-Coated Pedicle Screw systems. Further, the company noted that 2015 was the company’s 6th consecutive year of double-digit revenue growth.

Mar 14, 2016

Implanet Initiates Prospective, Multicenter Clinical Study of JAZZ Band

ORTHOFLASH Spine

Implanet commenced a prospective, multicenter clinical study to document outcomes with the JAZZ Band™ implant in adult degenerative and deformity indications.

Mar 14, 2016

Medicrea Launches UNiD Lab Support for Patient-Specific Spine Surgery

ORTHOFLASH Spine

Medicrea has launched UNiD™ Lab Services, including real-time support for pre-op planning of spinal procedures, order fulfillment for the UNiD patient-specific rod and detailed post-op analysis.

Mar 14, 2016

Maxx Orthopedics Launches Freedom PCK Revision Knee

Joint Replacement ORTHOFLASH

Maxx Orthopedics announced launch and initial procedures using the Freedom® PCK revision knee.

Mar 11, 2016

FDA Proposes Reclassification of Posterior Cervical Screws

ORTHOFLASH Spine

FDA is proposing to classify posterior cervical screw systems into Class II (special controls) and to continue to require premarket notification for the devices.

Mar 11, 2016

Medtech Logs First Sale of ROSA Spine in the U.S.

ORTHOFLASH Robotics/Tech

Medtech announced the 1st sale of its ROSA™ Spine robotic surgery system in the U.S.

Mar 10, 2016

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

Company Updates Competitive Landscape

Strategic orthopaedic-related 510(k)s issued in February 2016 include: C-VBR (Cardinal Spine), Lateral Interbody System (Cogent Spine), M-Fix Acromioclavicular Device (Coracoid Solutions*), Extremity Plate System (Epic Extremity), Winch Kyphoplasty Gauge (G21), MiniARS Screws (Overmed*), Irene Locking Compression Plate (Tianjin Zhengtian Medical Instrument*), trauma Screw (Tyber Medical), Comprehensive SRS/Nexel Elbow (Zimmer Biomet)

Mar 10, 2016

Wenzel Spine Announces Limited Release of the Next-Gen VariLift-LX

ORTHOFLASH Spine

Wenzel Spine commenced limited launch of the VariLift®-LX system for minimally invasive lumbar fusion. Full launch is planned for spring 2016.

Mar 09, 2016

NuVasive Receives Regulatory Approval of ReLine™ Posterior Fixation in Japan

ORTHOFLASH Spine

NuVasive received regulatory approval for ReLine™ posterior fixation technology in Japan. Launch will commence later in 2016 and continue into 2017.

Mar 09, 2016

BioMedical Enterprises Launches the Elite Nitinol Bone Fixation System

ORTHOFLASH Trauma

BioMedical Enterprises (BME) commenced U.S. launch of the BME Elite® Nitinol Bone Fixation system, designed to offer high strength, stiffness and rotational stability for high-load applications.

Mar 09, 2016

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