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54 catalysts · 19 device recall · 13 device 510k · 12 device pma · 8 approval · 2 grant
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54 catalysts · 19 device recall · 13 device 510k · 12 device pma · 8 approval · 2 grant
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3. — Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). — Status: Ongoing
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314. — Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). — Status: Ongoing
NS grant. $577,611. PI: Shella D Keilholz
DK grant. $859,998. PI: ROSEMARY V SAMPOGNA