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DePuy Synthes

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233696DePuy Synthes Retrograde Femoral Nail Advanced SystemAugust 1, 2024
K233255CROSSNAV Navigation Enabled InstrumentsJune 17, 2024
K233256Robotic Integration InstrumentsJune 17, 2024
K233254TELIGEN System Navigation Ready InstrumentsJune 14, 2024
K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating SystemMarch 21, 2024
K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemJuly 26, 2023
K221809DePuy Synthes 3.5mm Intrapelvic Acetabular SystemSeptember 20, 2022
K213563DePuy Synthes Radial Head Replacement SystemMarch 18, 2022
K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)June 2, 2021
K203414DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate SysDecember 16, 2020
K201959DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate SystemSeptember 11, 2020
K201321DePuy Synthes 2.7mm VA LCP Clavicle Plate SystemJuly 24, 2020
K190750DePuy Synthes Plates and Screws PortfolioJune 21, 2019
K190409MatrixRIB Fixation SystemMay 3, 2019
K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDecember 26, 2018
K172872DePuy Synthes Femoral Neck SystemMarch 5, 2018
K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning PinsMarch 29, 2017
K163046DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-LongFebruary 9, 2017
K151885SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemSeptember 3, 2015
K792352SYNTHES CERVICAL VERTABRAE PLATESDecember 6, 1979