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
FDA 510(k) Regulatory Record - I.T.S. GmbH Orthopedic ✕
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