Nexa Bone Plate and Screw System
FDA 510(k) K053408 · Nexa Orthopedics, Inc.
510(k) numberK053408
Submission
- Device name
- Nexa Bone Plate and Screw System
- Applicant
- Nexa Orthopedics, Inc.
San Diego, CA, US - Received
- December 7, 2005
- Decision date
- December 22, 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 |
|---|---|---|
| K072710 | Nexfix Compression PinJDW · Traditional | 11/08/2007SE |
| K071147 | Nexa Orthopedics Total Shoulder SystemKWT · Traditional | 07/20/2007SE |
| K070688 | Nexfix Compression StapleJDR · Traditional | 05/18/2007SE |
| K060386 | Nexa Carpo Metacarpal ImplantKYI · Traditional | 05/10/2006SE |
| K060071 | Nexa Compression ScrewHWC · Traditional | 01/26/2006SE |
| K053394 | Nexa Bone Screw SystemHWC · Traditional | 12/14/2005SE |
| K051740 | Tapered Compression PinJDW · Traditional | 09/06/2005SE |
| K051406 | Osteocure Resorbable Bead KitMQV · Traditional | 08/01/2005SE |
| K033046 | Subtalar Peg ImplantMJW · Traditional | 12/23/2003SE |
| K032902 | Subtalar Arthrorisis ImplantHWC · Traditional | 12/15/2003SE |
Questions and answers
When was Nexa Bone Plate and Screw System cleared by the FDA?
Nexa Bone Plate and Screw System (K053408) received a 510(k) decision of Substantially Equivalent on December 22, 2005, 15 days after the submission was received.
What is the product code of K053408?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.