I.T.S. GmbH is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
I.T.S. GmbH - FDA 510(k) Cleared Devices
Recent clearances: I.T.S. PRS Phoenix II, I.T.S. INS Proximal Femur Nail, I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
8
Total
8
Cleared
0
Denied
I.T.S. GmbH has 8 FDA 510(k) cleared medical devices. Based in Prior Lake, US.
Latest FDA clearance: Jun 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 and Qserve Group, Us, Inc..
FDA 510(k) Regulatory Record - I.T.S. GmbH
8 devices
Cleared
Jun 16, 2026
I.T.S. Clavicle Plates with Angular Stability
Orthopedic
85d
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