Newdeal Compression Plate
FDA 510(k) K091609 · Newdeal Sas
510(k) numberK091609
Submission
- Device name
- Newdeal Compression Plate
- Applicant
- Newdeal Sas
Planisboro, NJ, US - Received
- June 3, 2009
- Decision date
- June 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K103623 | Newdeal Interphalangeal ImplantHTY · Traditional | 03/20/2012SE |
| K093914 | Newdeal Compression PlatesHRS · Traditional | 04/14/2011SE |
| K093781 | Modified: Newdeal Hallu PlatesHRS · Special | 01/22/2010SE |
| K091788 | Panta Nail (Dia. 10MM), Panta Nail XLHSB · Special | 07/29/2009SE |
| K083154 | Newdeal Hallu Lock Plate SystemHRS · Traditional | 07/10/2009SE |
| K073375 | Newdeal Tibiaxys SystemHRS · Traditional | 02/21/2008SE |
| K071639 | Qwix Positioning ScrewHWC · Special | 07/09/2007SE |
| K070447 | Newdeal Compression PlateHRS · Traditional | 03/29/2007SE |
| K063831 | Basal Dorsal PlatesHRS · Traditional | 02/07/2007SE |
Questions and answers
When was Newdeal Compression Plate cleared by the FDA?
Newdeal Compression Plate (K091609) received a 510(k) decision of Substantially Equivalent on June 30, 2009, 27 days after the submission was received.
What is the product code of K091609?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.