Tyber Medical receives FDA clearance, MRI conditional labeling of anatomic plating system
Click Here to Manage Email Alerts
Key takeaways:
- FDA 510(k) clearance expands the anatomical plating system portfolio by Tyber Medical.
- FDA magnetic resonance labeling clears the system for safe use in the MRI environment under certain tested conditions.
Tyber Medical LLC has announced FDA 510(k) clearance and magnetic resonance conditional labeling of 100 new anatomic plates for use in orthopedic trauma, extremity and spine surgery, according to a press release.
The FDA clearance expands the anatomical plating system portfolio from Tyber Medical, which includes 391 plate configurations to treat deformities, trauma and degenerative conditions of the wrist, foot, ankle and long bones, according to the release.
“Our latest 510(k) clearance, including the [magnetic resonance] MR conditional designation from the FDA, expands the scope and impact of our product portfolio, giving our customers rapid access to a greater breadth of regulatory-cleared, innovative orthopedic devices that enhance patient care,” Logan Schleicher, senior design engineer at Tyber Medical, said in the release. “The MR conditional labeling is an important designation that brings greater value to the full portfolio of orthopedic plating devices we offer to our customers,” Schleicher added.
Read more about
Click Here to Manage Email Alerts