Dunamis, LLC is one of 13015 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Dunamis, LLC - FDA 510(k) Cleared Devices
Recent clearances: Dunamis PunchTac Suture Anchors, Dunamis Fixation Button System, Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
6
Total
6
Cleared
0
Denied
Dunamis, LLC has 6 FDA 510(k) cleared medical devices. Based in Greenville, US.
Historical record: 6 cleared submissions from 2015 to 2020. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Dunamis, LLC Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Lexamed, Mcra, LLC and Compliance Systems International, LLC.
FDA 510(k) Regulatory Record - Dunamis, LLC
6 devices
Cleared
Feb 14, 2020
Dunamis PunchTac Suture Anchors
Orthopedic
81d
Cleared
Aug 29, 2019
Dunamis Fixation Button System
Orthopedic
106d
Cleared
Jul 06, 2016
Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
Orthopedic
89d
Cleared
Mar 03, 2016
Dunamis Force DFX Tensile Tape
General & Plastic Surgery
65d
Cleared
Oct 14, 2015
Dunamis Interference Screw
Orthopedic
160d
Cleared
Jun 29, 2015
Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2
General & Plastic Surgery
139d