I.T.S. GmbH
Medical device manufacturer in Laßnitzhöhe, AT.
8510(k) clearances
0PMA approvals
18recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…HRS · Traditional | 06/16/2026SE |
| K260054 | I.T.S. PRS Phoenix IIHRS · Traditional | 04/24/2026SE |
| K233134 | I.T.S. INS Proximal Femur NailHSB · Traditional | 02/12/2024SE |
| K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)HRS · Traditional | 08/31/2022SE |
| K142418 | I.T.S. Hand Locking Plates System - HLSHRS · Traditional | 09/26/2014SE |
| K132945 | Cfn-Cannulated Femur Nail, Ctn-Cannulated Tibia Nail, Chn-Cannulated Humeral NailHSB · Traditional | 03/07/2014SE |
| K131722 | I.T.S. Extremity Fixation SystemsHRS · Traditional | 08/07/2013SE |
| K130008 | Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…HRS · Traditional | 06/25/2013SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1608-2026 Class II | Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1607-2026 Class II | HLS - Hand Locking Plates System with the below descriptions and corresponding article…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1606-2026 Class II | HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1605-2026 Class II | FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1604-2026 Class II | I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1603-2026 Class II | I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1602-2026 Class II | Distal Humeral Plates with Angular Stability with the below descriptions and…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1601-2026 Class II | I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1600-2026 Class II | Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1599-2026 Class II | I.T.S. Screw System with the below descriptions and corresponding article numbers. 1.…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1598-2026 Class II | I.T.S. Straight Plate with Angular Stability with the below descriptions and…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1597-2026 Class II | Olecranonplate with Angular Stability with the below descriptions and corresponding…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1596-2026 Class II | Pilonplate with Angular Stability, with the below descriptions and corresponding article…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1595-2026 Class II | FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1594-2026 Class II | Brand Name: Humeral Head Plate with Angular Stability, with the following description:…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1593-2026 Class II | Claviculaplate with Angular Stability, with the below descriptions and associated…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1592-2026 Class II | Volar Radius Plate with Angular Stability with the following description: Radius Plate…Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions… | 01/23/2026Open, Classified |
| Z-1718-2019 Class II | Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The…The titanium implant has the wrong article number laser marked on it. | 05/09/2019Open, Classified |