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Synthes USA Products, LLC

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

Total Devices6
Categories5
Latest Approval2018-11-21
TypeNumberDevice NameCodeDate
510(k) K180541 DePuy Synthes 2.0 mm Quick Insertion Screws HWC 2018-11-21 View
510(k) K170818 Craniomaxillofacial Distraction System (CMFD) PBJ 2017-12-07 View
510(k) K162594 Craniomaxillofacial Distraction System (CMFD) MQN 2017-05-08 View
510(k) K170654 USS System NKB 2017-03-29 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 Screw HWC 2017-02-16 View
510(k) K162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System MAX 2016-11-01 View