Spineart Announces BAGUERA C Milestone
As of 2Q15, >15,000 of Spineart’s BAGUERA® C cervical disc replacement devices have been successfully implanted worldwide. Jun 13, 2016
Amedica Submits Response to FDA for Clearance of Composite Interbody Spinal Device
Amedica submitted its responses to FDA in relation to the CASCADE clinical trial, and expects a final determination from FDA within 60 days. Jun 13, 2016
curasan to Expand in the U.S. and China
curasan will invest in targeted expansion of sales and marketing activities in the U.S. and China. The company markets CERASORB® bone void filler products. Jun 13, 2016
Titan Spine Enhances Endoskeleton Warranty
Titan Spine is amending its device warranty to provide a free replacement if any Endoskeleton® interbody fusion devices delaminate or generate particulate debris during implantation. Jun 13, 2016
SI-BONE Receives 510(k) Clearance on Updated Indication for iFuse Implant
SI-BONE received FDA 510(k) clearance of a modified indication for the iFuse Implant System®, noting that clinical studies have demonstrated its ability to improve pain, patient function and quality of life. Jun 13, 2016
Amplitude Surgical Files for ANATOMIC Knee 510(k)
Amplitude Surgical filed for FDA 510(k) clearance of its posterior stabilized ANATOMIC® knee prosthesis. Jun 09, 2016
Corin Receives FDA Clearance to Market the Optimized Positioning System
Corin received FDA 510(k) clearance to market the Optimized Positioning System (OPSâ„¢), reportedly the first FDA-cleared technology to support functional, patient-specific component alignment in total hip replacement. Jun 09, 2016
Avitus Orthopaedics Receives 510(k) Clearance, Launches Avitus Bone Harvester
Avitus Orthopaedics launched pilot sales of the Avitusâ„¢ Bone Harvester. Jun 08, 2016
Xtant Medical, Pinnacle Spine Distribution Agreement
Xtant Medical and Pinnacle Spine entered into a joint agreement to expand distribution of Pinnacle’s InFill® Lateral Lumbar Interbody Fusion system. Jun 08, 2016
Zimmer Biomet Acquiring LDR
Zimmer Biomet entered into a definitive agreement to acquire LDR for US $37/share in cash, for a transaction valued at ~$1.0BB with an expected 3Q16 close. Jun 07, 2016
