Ortho Solutions Ultos Plating System
FDA 510(k) K141784 · Ortho Solutions Limited
510(k) numberK141784
Submission
- Device name
- Ortho Solutions Ultos Plating System
- Applicant
- Ortho Solutions Limited
Prior Lake, MN, US - Received
- July 2, 2014
- Decision date
- July 23, 2014
- 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
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K121575 | Oxford Ankle Fusion Nail(Afn) SystemHSB · Traditional | 09/14/2012SE |
| K120360 | Ortho Solutions Trauma Plates for OsteosysnthesisHRS · Traditional | 05/29/2012SE |
| K111678 | Ortho Solutions Extremity Fixation Implants for OsteosysnthesisHRS · Traditional | 02/07/2012SE |
| K110895 | Ortho Solutions Trauma Implants for OsteosynthesisHWC · Traditional | 12/19/2011SE |
| K102743 | Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresHWE · Traditional | 01/20/2011SE |
Questions and answers
When was Ortho Solutions Ultos Plating System cleared by the FDA?
Ortho Solutions Ultos Plating System (K141784) received a 510(k) decision of Substantially Equivalent on July 23, 2014, 21 days after the submission was received.
What is the product code of K141784?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.