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Legal, Clinical & Regulatory

FDA 510(k) Recap: First Clearances for Companies in 1Q21

New year, new entrants to the U.S. orthopedic market. This installation of the 510(k) recap offers up companies based in the U.S., China and Switzerland, and spans four of the major industry segments: Joint Replacement, Spine, Trauma and Sports Medicine.   

DePuy Synthes Gains FDA Clearance for VELYS Robot with ATTUNE Knee

The VELYS Robotic-Assisted Solution adapts to the surgical workflow, and helps surgeons execute accurate bony cuts.   

EU Allows Notified Bodies to Conduct Audits Remotely

While remote auditing will be conducted on a case-by-case basis, Notified Bodies and members of industry expect the shift could ease the backlog created by MDR and COVID.