Shoulder Nail Plate
FDA 510(k) K052294 · Hand Innovations, LLC
510(k) numberK052294
Submission
- Device name
- Shoulder Nail Plate
- Applicant
- Hand Innovations, LLC
Miami Lakes, FL, US - Received
- August 23, 2005
- Decision date
- October 21, 2005
- 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 |
|---|---|---|
| K061748 | Fragment Plate SystemKTT · Special | 07/17/2006SE |
| K060864 | Multidirectional Threaded PegLXT · Special | 04/28/2006SE |
| K060294 | Diaphyseal PlateHRS · Traditional | 03/22/2006SE |
| K060290 | Shoulder Fixation SystemLXT · Special | 02/27/2006SE |
| K052248 | Dorsal Nail Plate, AnatomicalHRS · Special | 09/14/2005SE |
| K051728 | Modification to Shoulder Fixation SystemLXT · Special | 07/20/2005SE |
| K050932 | Distal Volar Radius Anatomical Plate SystemLXT · Special | 04/26/2005SE |
| K042059 | Shoulder Fixation SystemLXT · Traditional | 09/30/2004SE |
| K041157 | Modification to Small Bone Fixation SystemHTY · Traditional | 07/30/2004SE |
| K041081 | Fragment Plate System, Screws, Pins and K-WiresKTT · Traditional | 07/01/2004SE |
Questions and answers
When was Shoulder Nail Plate cleared by the FDA?
Shoulder Nail Plate (K052294) received a 510(k) decision of Substantially Equivalent on October 21, 2005, 59 days after the submission was received.
What is the product code of K052294?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.