Integra LifeSciences Corporation - FDA 510(k) Cleared Devices
Recent clearances: CUSA® Clarity Ultrasonic Surgical Aspirator System, AURORA® Surgiscope® System (ASX15/60), CUSA® Clarity Ultrasonic Surgical Aspirator System
65
Total
65
Cleared
0
Denied
FDA 510(k) Regulatory Record - Integra LifeSciences Corporation Orthopedic ✕
13 devices
Cleared
Jul 27, 2021
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot...
Orthopedic
204d
Cleared
Jun 29, 2020
Cadence Total Ankle System
Orthopedic
24d
Cleared
Dec 02, 2019
Integra TITAN Reverse Shoulder System
Orthopedic
270d
Cleared
Nov 02, 2018
Panta 2 Arthrodesis Nail System
Orthopedic
134d
Cleared
Oct 12, 2018
Integra TITAN Reverse Shoulder System
Orthopedic
78d
Cleared
Jun 21, 2018
Integra TITAN Reverse Shoulder System
Orthopedic
198d
Cleared
Aug 25, 2016
Integra TITAN Reverse Shoulder System
Orthopedic
120d
Cleared
Mar 24, 2014
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
Orthopedic
248d
Cleared
Dec 21, 2012
INTEGRA TOTAL FOOT SYSTEMS
Orthopedic
85d
Cleared
Dec 15, 2009
INTEGRA TOTAL WRIST FUSION SYSTEM
Orthopedic
70d
Cleared
Dec 04, 2009
INTEGRA MOZAIK AND OS MOLDABLE MORSELS
Orthopedic
214d
Cleared
Dec 20, 2006
MOZAIK BONE REGENERATION MATRIX - PUTTY
Orthopedic
131d
Cleared
Jun 17, 2004
INTEGRA BONE FIXATION SYSTEM
Orthopedic
76d