FDA 510(k) Applications Submitted by Synthes (USA) products, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K172157 |
07/18/2017 |
DePuy Synthes Femoral Recon Nail System |
Synthes (USA) Products, LLC |
| K160167 |
01/27/2016 |
DePuy Synthes TFNA Augmentation System |
Synthes (USA) Products, LLC |
| K170802 |
03/17/2017 |
TRAUMACEMÖ V+ Injectable Bone Cement |
Synthes (USA) Products, LLC |
| K212943 |
09/15/2021 |
SyntheCel Dura Repair |
Synthes (USA) products, LLC |
| K210408 |
02/11/2021 |
DePuy Synthes Variable Angle Locking Patella Plating System |
Synthes (USA) Products, LLC |
| K201578 |
06/11/2020 |
DePuy Synthes Variable Angle Locking Patella Plating System |
Synthes (USA) Products, LLC |
| K131548 |
05/30/2013 |
SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM |
SYNTHES (USA) PRODUCTS, LLC |
| K201346 |
05/21/2020 |
DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm |
Synthes (USA) Products, LLC |
| K191463 |
06/03/2019 |
DePuy Synthes Hammertoe Continuous Compression Implant |
Synthes (USA) Products, LLC |
| K150099 |
01/20/2015 |
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) |
SYNTHES (USA) PRODUCTS, LLC |
| K201336 |
05/20/2020 |
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm |
Synthes (USA) Products, LLC |
| K201944 |
07/13/2020 |
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) |
Synthes (USA) Products, LLC |
| K210205 |
01/26/2021 |
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System |
Synthes (USA) products, LLC |
| K180213 |
01/25/2018 |
Titanium TomoFix Medial High Tibia Plate Anatomical |
Synthes (USA) Products, LLC |
| K182154 |
08/09/2018 |
Depuy Synthes Femoral Neck System |
Synthes (USA) Products, LLC |
| K180544 |
03/01/2018 |
DePuy Synthes Static Staples |
Synthes (USA) Products, LLC |
| K211313 |
04/30/2021 |
MAXFRAME Multi-Axial Correction System (aka MAXFRAME) |
Synthes (USA) Products, LLC |
| K150796 |
03/26/2015 |
Dental Bone Cutting Instruments |
SYNTHES (USA) PRODUCTS, LLC |
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