Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking
FDA 510(k) K130008 · I.T.S. GmbH
510(k) numberK130008
Submission
- Device name
- Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking
- Applicant
- I.T.S. GmbH
Prior Lake, MN, US - Received
- January 2, 2013
- Decision date
- June 25, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 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 |
Questions and answers
When was Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking cleared by the FDA?
Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking (K130008) received a 510(k) decision of Substantially Equivalent on June 25, 2013, 174 days after the submission was received.
What is the product code of K130008?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.