Medical Device Manufacturer · US , West Chester , PA

Synthes USA Products, LLC - FDA 510(k) Cleared Devices

60 submissions · 60 cleared · Since 2010
60
Total
60
Cleared
0
Denied

Synthes USA Products, LLC has 60 FDA 510(k) cleared orthopedic devices. Based in West Chester, US.

Last cleared in 2022. Active since 2010.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

60 devices
1–12 of 60
SyntheCel Dura Repair
K212943 · GXQ Dura Substitute · Neurology
Jan 2022 135d
MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
K211313 · KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · Orthopedic
May 2021 25d
DePuy Synthes Variable Angle Locking Patella Plating System
K210408 · HRS Plate, Fixation, Bone · Orthopedic
Apr 2021 56d
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
K210205 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2021 59d
DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
K201346 · HSB Rod, Fixation, Intramedullary And Accessories · Orthopedic
Sep 2020 125d
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
K192702 · GXN Plate, Cranioplasty, Preformed, Non-alterable · Neurology
Sep 2020 357d
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
K201944 · JEY Plate, Bone · Dental
Sep 2020 59d
DePuy Synthes Variable Angle Locking Patella Plating System
K201578 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2020 90d
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
K201336 · JDS Nail, Fixation, Bone · Orthopedic
Sep 2020 106d
DePuy Synthes Hammertoe Continuous Compression Implant
K191463 · JDR Staple, Fixation, Bone · Orthopedic
Feb 2020 268d
Depuy Synthes Maxillofacial Portfolio - MR Conditional
K192655 · JEY Plate, Bone · Dental
Dec 2019 96d
DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
K192327 · HRS Plate, Fixation, Bone · Orthopedic
Nov 2019 72d

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All60 Orthopedic 44 Dental 7 Neurology 6 General & Plastic Surgery 2 General Hospital 1