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Synthes USA Products, LLC

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories5
Latest FDA decision2018-11-21
TypeNumberDevice NameCodeDateActions
510(k) K180541 DePuy Synthes 2.0 mm Quick Insertion ScrewsHWC2018-11-21 View
510(k) K170818 Craniomaxillofacial Distraction System (CMFD)PBJ2017-12-07 View
510(k) K162594 Craniomaxillofacial Distraction System (CMFD)MQN2017-05-08 View
510(k) K170654 USS SystemNKB2017-03-29 View
510(k) K161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression ScrewHWC2017-02-16 View
510(k) K162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemMAX2016-11-01 View