PL8 Wrist Reconstruction Plate
FDA 510(k) K180150 · Citieffe S.R.L.
510(k) numberK180150
Submission
- Device name
- PL8 Wrist Reconstruction Plate
- Applicant
- Citieffe S.R.L.
Calderara Di Reno, IT - Received
- January 19, 2018
- Decision date
- August 2, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K250197 | Estremo Fibular NailHSB · Traditional | 10/17/2025SE |
| K183666 | EBA One Nailing SystemHSB · Traditional | 11/14/2019SE |
| K181540 | Estremo Citieffe Nailing SystemHSB · Traditional | 01/16/2019SE |
| K163323 | Dolphix® External Fixation System MR ConditionalKTT · Traditional | 03/20/2017SE |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With HydroxyapatiteJDW · Traditional | 07/07/2015SE |
| K132363 | Dolphix External Fixation SystemKTT · Traditional | 01/16/2014SE |
| K131005 | EBA2 Femoral Nailing SystemHSB · Special | 06/25/2013SE |
Questions and answers
When was PL8 Wrist Reconstruction Plate cleared by the FDA?
PL8 Wrist Reconstruction Plate (K180150) received a 510(k) decision of Substantially Equivalent on August 2, 2018, 195 days after the submission was received.
What is the product code of K180150?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.