Year in Review: First 510(k)s in 2016
The following 18 companies received their first FDA 510(k) in 2016. Whats interesting is that some companies like CG Bio,...
The following 18 companies received their first FDA 510(k) in 2016. Whats interesting is that some companies like CG Bio,...
Orthofix reached final resolutions of two previously-disclosed SEC investigations and agreed to pay ~US $14.0MM to settle charges regarding historic accounting...
Bovie Medical entered into a global sales channel partnership agreement with CONMED for its PlazXact™ Ablator, which will be marketed as...
WishBone Medical has formed to provide anatomically-appropriate orthopaedic implants and instruments in sterile-packed, single-use, disposable kits for the pediatric market....
Bioventus selected MEDSERVICE to distribute DUROLANE® single-injection joint fluid in Russia. ...
Zimmer Biomet (ZBH) concluded agreements with the U.S. DOJ and SEC to resolve previously-disclosed matters involving Biomet. A $30.5MM payment...
Orthocell entered into a research collaboration agreement with DePuy Synthes Products for the Ortho-ATI® stem cell treatment for tendon and ligament...
OssDsign entered into new commercial partnerships covering distribution of its products for cranial repair and facial bone reconstruction in Italy,...
Medovex entered into an international distribution agreement with AlfaMed for distribution of its DenerveX™ System throughout Italy....
Strategic orthopaedic-related 510(k)s issued in December 2016 include: Envision 3D Image Guidance System (7D Surgical); Sphynx Anterolateral Plate (Eden Spine);...
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