Medical Device Manufacturer · US , West Chester , PA

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

60 submissions · 60 cleared · Since 2010

Recent clearances: SyntheCel Dura Repair, MAXFRAME Multi-Axial Correction System (aka MAXFRAME), DePuy Synthes Variable Angle Locking Patella Plating System

60

Total

60

Cleared

0

Denied

FDA 510(k) Regulatory Record - Synthes USA Products, LLC Neurology ✕

6 devices

1-6 of 6

Cleared Jan 28, 2022

SyntheCel Dura Repair

Neurology · 135d

Cleared Sep 18, 2020

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

Neurology · 357d

Cleared Dec 07, 2017

Craniomaxillofacial Distraction System (CMFD)

Neurology · 262d

Cleared Jan 18, 2017

Taps for Resorbable Screws

Neurology · 399d

Cleared Jun 13, 2014

MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)

Neurology · 109d

Cleared Sep 23, 2010

NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY

Neurology · 66d