Synthes USA Products, LLC - FDA 510(k) Cleared Devices
Recent clearances: MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System, SyntheCel Dura Repair, MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
61
Total
61
Cleared
0
Denied
FDA 510(k) Regulatory Record - Synthes USA Products, LLC Orthopedic ✕
45 devices
Cleared
Jun 11, 2026
MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System
Orthopedic
175d
Cleared
May 25, 2021
MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
Orthopedic
25d
Cleared
Apr 08, 2021
DePuy Synthes Variable Angle Locking Patella Plating System
Orthopedic
56d
Cleared
Mar 26, 2021
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur...
Orthopedic
59d
Cleared
Sep 23, 2020
DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking...
Orthopedic
125d
Cleared
Sep 09, 2020
DePuy Synthes Variable Angle Locking Patella Plating System
Orthopedic
90d
Cleared
Sep 03, 2020
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary...
Orthopedic
106d
Cleared
Feb 26, 2020
DePuy Synthes Hammertoe Continuous Compression Implant
Orthopedic
268d
Cleared
Nov 07, 2019
DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
Orthopedic
72d
Cleared
Jul 23, 2019
DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
Orthopedic
102d
Cleared
Nov 21, 2018
DePuy Synthes 2.0 mm Quick Insertion Screws
Orthopedic
265d
Cleared
Oct 19, 2018
Titanium TomoFix Medial High Tibia Plate Anatomical
Orthopedic
267d
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