Medical Device Manufacturer · US , Raynham , MA

DePuy Synthes

19 submissions · 19 cleared · Since 1979
19
Total
19
Cleared
0
Denied

DePuy Synthes — FDA 510(k) Submissions

DePuy Synthes has submitted 19 FDA 510(k) premarket notifications since 1979, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plate, Fixation, Bone, Orthopedic Stereotaxic Instrument, Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Rod, Fixation, Intramedullary And Accessories, Appliance, Fixation, Spinal Intervertebral Body . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
DePuy Synthes Retrograde Femoral Nail Advanced System
K233696 · HSB Rod, Fixation,... · Orthopedic
Aug 2024 258d
CROSSNAV Navigation Enabled Instruments
K233255 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2024 263d
Robotic Integration Instruments
K233256 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2024 263d
TELIGEN System Navigation Ready Instruments
K233254 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2024 260d
DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
K233665 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2024 127d
DEPUY SYNTHES MAXFRAME AUTOSTRUT System
K231922 · KTT Appliance, Fixation,... · Orthopedic
Jul 2023 27d
DePuy Synthes 3.5mm Intrapelvic Acetabular System
K221809 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2022 90d
DePuy Synthes Radial Head Replacement System
K213563 · KWI Prosthesis, Elbow, Hemi-,... · Orthopedic
Mar 2022 129d
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
K211051 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2021 55d
DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
K203414 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2020 27d
DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
K201959 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2020 59d
DePuy Synthes 2.7mm VA LCP Clavicle Plate System
K201321 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2020 67d
DePuy Synthes Plates and Screws Portfolio
K190750 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2019 88d
MatrixRIB Fixation System
K190409 · HRS Plate, Fixation, Bone · Orthopedic
May 2019 71d
DePuy Synthes Trauma Orthopedic Nail Implants
K182783 · HRS Plate, Fixation, Bone · Orthopedic
Dec 2018 86d
DePuy Synthes Femoral Neck System
K172872 · KTT Appliance, Fixation,... · Orthopedic
Mar 2018 165d
Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
K162124 · JDP Condylar Plate Fixation... · Orthopedic
Mar 2017 240d
DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long
K163046 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2017 100d
SYNTHES CERVICAL VERTABRAE PLATES
K792352 · KWQ Appliance, Fixation,... · Orthopedic
Dec 1979 17d
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