I.T.S. GmbH - FDA 510(k) Cleared Devices
7
Total
7
Cleared
0
Denied
I.T.S. GmbH has 7 FDA 510(k) cleared medical devices. Based in Prior Lake, US.
Latest FDA clearance: Apr 2026. Active since 2013. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by I.T.S. GmbH Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Qserve Group, Us, Inc. and Qserve Group US.
7 devices
Cleared
Apr 24, 2026
I.T.S. PRS Phoenix II
Orthopedic
106d
Cleared
Feb 12, 2024
I.T.S. INS Proximal Femur Nail
Orthopedic
138d
Cleared
Aug 31, 2022
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
Orthopedic
520d
Cleared
Sep 26, 2014
I.T.S. Hand Locking Plates System - HLS
Orthopedic
29d
Cleared
Mar 07, 2014
CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL...
Orthopedic
169d
Cleared
Aug 07, 2013
I.T.S. EXTREMITY FIXATION SYSTEMS
Orthopedic
56d
Cleared
Jun 25, 2013
DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0...
Orthopedic
174d