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Synthes (USA) Products, LLC

FDA 510(k) & PMA Approved Devices — 45 products

Total Devices45
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K254087 MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemKTT2026-06-11 View
510(k) K212943 SyntheCel Dura RepairGXQ2022-01-28 View
510(k) K211313 MAXFRAME Multi-Axial Correction System (aka MAXFRAME)KTT2021-05-25 View
510(k) K210408 DePuy Synthes Variable Angle Locking Patella Plating SystemHRS2021-04-08 View
510(k) K210205 DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemHRS2021-03-26 View
510(k) K201346 DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mmHSB2020-09-23 View
510(k) K192702 DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalGXN2020-09-18 View
510(k) K201944 DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)JEY2020-09-10 View
510(k) K201578 DePuy Synthes Variable Angle Locking Patella Plating SystemHRS2020-09-09 View
510(k) K201336 DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmJDS2020-09-03 View
510(k) K191463 DePuy Synthes Hammertoe Continuous Compression ImplantJDR2020-02-26 View
510(k) K192655 Depuy Synthes Maxillofacial Portfolio - MR ConditionalJEY2019-12-30 View
510(k) K192327 DePuy Synthes 2.4mm LCP Straight Wrist Plate, SterileHRS2019-11-07 View
510(k) K190963 DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalHRS2019-07-23 View
510(k) K183472 DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR ConditionalFTM2019-03-13 View
510(k) K183113 DePuy Synthes Maxillofacial Portfolio - MR ConditionalMQN2019-03-13 View
510(k) K180541 DePuy Synthes 2.0 mm Quick Insertion ScrewsHWC2018-11-21 View
510(k) K180213 Titanium TomoFix Medial High Tibia Plate AnatomicalHRS2018-10-19 View
510(k) K182154 Depuy Synthes Femoral Neck SystemKTT2018-10-16 View
510(k) K180544 DePuy Synthes Static StaplesJDR2018-07-24 View
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