Ascension Orthopedics is one of 13017 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ascension Orthopedics - FDA 510(k) Cleared Devices
Recent clearances: Integra Salto Total Ankle System, Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System, Integra External Fixation System
7
Total
7
Cleared
0
Denied
Ascension Orthopedics has 7 FDA 510(k) cleared medical devices. Based in Austin, US.
Historical record: 7 cleared submissions from 2014 to 2018. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Ascension Orthopedics Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Integra LifeSciences Corporation, Integra Life Sciences and Coorstek Medical.
FDA 510(k) Regulatory Record - Ascension Orthopedics
7 devices
Cleared
Dec 18, 2018
Integra Salto Total Ankle System
Orthopedic
64d
Cleared
Jul 14, 2017
Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
Orthopedic
346d
Cleared
Jul 06, 2016
Integra External Fixation System
Orthopedic
103d
Cleared
Dec 23, 2015
INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
Orthopedic
153d
Cleared
Oct 29, 2015
Integra DigiFuse Cannulated Intramedullary Fusion System
Orthopedic
56d
Cleared
Aug 31, 2015
Integra Total Ankle Replacement System
Orthopedic
91d
Cleared
Nov 14, 2014
TITAN Modular Total Shoulder System
Orthopedic
78d