Synthes (Usa), LLC is one of 12945 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Synthes (Usa), LLC - FDA 510(k) Cleared Devices
Recent clearances: TruMatch Graft Cage - Long Bone, DePuy Synthes MAXFRAME Multi-Axial Correction System, Zero-P Natural Plate System
7
Total
7
Cleared
0
Denied
Synthes (Usa), LLC has 7 FDA 510(k) cleared medical devices. Based in 19380, US.
Historical record: 7 cleared submissions from 2010 to 2018. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Synthes (Usa), LLC Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Synthes USA, LLC and DePuy Synthes.
FDA 510(k) Regulatory Record - Synthes (Usa), LLC
7 devices
Cleared
Dec 21, 2018
TruMatch Graft Cage - Long Bone
Orthopedic
266d
Cleared
Nov 10, 2016
DePuy Synthes MAXFRAME Multi-Axial Correction System
Orthopedic
171d
Cleared
Dec 02, 2015
Zero-P Natural Plate System
Orthopedic
114d
Cleared
May 20, 2013
SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
Orthopedic
118d
Cleared
Jun 19, 2012
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
Orthopedic
340d
Cleared
May 25, 2012
SYNTHES ACIS/VERTEBRAL SPACER CR
Orthopedic
116d
Cleared
Sep 15, 2010
2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM
Orthopedic
104d