Data / Medical devices / Austria / I.T.S. GMBH
I.T.S. GMBH: FDA-registered device maker in LASSNITZHOEHE Steiermark, Austria, 20 510(k) clearances
I.T.S. GMBH is registered with the FDA (registration 3004369035) in LASSNITZHOEHE Steiermark, Austria. It lists 13 device types. The FDA files 20 510(k) clearances under its listings, the newest dated April 24, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004369035
- Address
- Autal 28, LASSNITZHOEHE Steiermark, Austria, A-8301
- Owner or operator
- I.T.S. GmbH (9059922)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 15, 2004
- Registered through
- 2026
- Brand names listed
- 2.7, 3.5, 4, 6.5, 7.3 Cannulated Screw & Washer Systems, Anterolateral Tibiaplate, BENDER, CAL - CALCANEUS locking PLATE, CALCANEUS DISTRACTOR, CFN - Cannulated Femur Nail System, CHN - Cannulated Humeral Nail System, CLS - ANTERIOR CLAVICLE locking PLATE - LATERAL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Component, Traction, Non-Invasive | KQZ | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Manufacturer | accessdata.fda.gov |
| Nail, Fixation, Bone | JDS | 2 | Manufacturer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone, Non-Spinal, Metallic | NDF | 2 | Manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone, Non-Spinal, Metallic | NDJ | 2 | Manufacturer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 24, 2026 | K260054 | I.T.S. PRS Phoenix II | HRS | Substantially Equivalent | I.T.S. GmbH | accessdata.fda.gov |
| February 12, 2024 | K233134 | I.T.S. INS Proximal Femur Nail | HSB | Substantially Equivalent | I.T.S. GmbH | accessdata.fda.gov |
| August 31, 2022 | K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) | HRS | Substantially Equivalent | I.T.S. GmbH | accessdata.fda.gov |
| September 26, 2014 | K142418 | I.T.S. Hand Locking Plates System - HLS | HRS | Substantially Equivalent | I.T.S. GmbH | accessdata.fda.gov |
| March 7, 2014 | K132945 | CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL | HSB | Substantially Equivalent | I.T.S. GmbH | accessdata.fda.gov |
| August 7, 2013 | K131722 | I.T.S. EXTREMITY FIXATION SYSTEMS | HRS | Substantially Equivalent | I.T.S. GmbH | accessdata.fda.gov |
| June 25, 2013 | K130008 | DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING | HRS | Substantially Equivalent | I.T.S. GmbH | accessdata.fda.gov |
| August 5, 2010 | K093868 | I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM | HRS | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| June 9, 2008 | K080706 | CONNEXX LOCKING TIBIA NAIL | JDS | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| March 26, 2008 | K080184 | DISTAL HUMERAL PLATES WITH ANGULAR STABILITY | HRS | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| February 2, 2007 | K063672 | FIBULA PLATE PROLOCK WITH ANGULAR STABILITY | HRS | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| December 22, 2006 | K063166 | I.T.S. PELVIC RECONSTRUCTION SYSTEM | HRS | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| March 20, 2006 | K060156 | STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM | HRS | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| October 17, 2005 | K052368 | OLECRANONPLATE WITH ANGULAR STABILITY | HRS | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| August 22, 2005 | K051642 | FR.O.H. CALCANEUS REPAIR SYSTEM | NDF | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| August 10, 2005 | K052011 | PILONPLATE WITH ANGULAR STABILITY | HRS | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| July 11, 2005 | K051412 | HUMERAL HEAD PLATE WITH ANGULAR STABILITY | HRS | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| June 22, 2005 | K050852 | CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM | HRS | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| February 24, 2005 | K043410 | EPIPHYSIS SCREW | HWC | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
| February 6, 2004 | K033756 | VOLAR RADIUS PLATE WITH ANGULAR STABILITY | HRS | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 23, 2026 | 98341 | Class II | Ongoing | Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3. | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | accessdata.fda.gov |
| May 9, 2019 | 82796 | Class II | Ongoing | Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can b | The titanium implant has the wrong article number laser marked on it. | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Screw, Fixation, Bone
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Nail, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Washer, Bolt Nut
Updated April 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.