FDA performed an inspection of Zimmer Biomet's Warsaw North Campus manufacturing facility in April 2018, and issued a Form 483 with 11 inspectional observations.Â
DePuy Synthes signed a definitive agreement to acquire the assets of Medical Enterprises Distribution, developer of the ME1000 Surgical Impactor for use in hip replacement. The transaction is slated to close in 2Q18.
Globus Medical reported 1Q18 revenue of US $174.4MM, +11.9% vs. 1Q17, and raised its full-year guidance to $695MM, based on increased uptake of the ExcelsiusGPS robotic system.Â
K2M posted 1Q18 revenue of US $67.9MM, +9.6% vs. 1Q17, and increased its full-year guidance range to $283MM-$287MM following partnership with a distributor in Portugal and Spain.