Distal Radius Fracture Fixation Plate System
FDA 510(k) K990596 · Avanta Orthopaedics, Inc.
510(k) numberK990596
Submission
- Device name
- Distal Radius Fracture Fixation Plate System
- Applicant
- Avanta Orthopaedics, Inc.
San Diego, CA, US - Received
- February 24, 1999
- Decision date
- April 29, 1999
- 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 |
|---|---|---|
| K030881 | Avanta Carpal Fusion Plating SystemHRS · Traditional | 04/10/2003SE |
| K021859 | Wrist ImplantJWJ · Traditional | 12/02/2002SE |
| K023604 | Modification to Radial Head ImplantKWI · Special | 11/27/2002SE |
| K013629 | Finger Joint ProsthesisKYJ · Traditional | 01/25/2002SE |
| K011819 | Radial Head ImplantKWI · Special | 06/19/2001SE |
| K010847 | K'FixNDL · Traditional | 06/19/2001SE |
| K003033 | Scaphix, Staple, Fixation, BoneJDR · Traditional | 05/30/2001SE |
| K010786 | Ulnar Head ImplantKXE · Special | 04/11/2001SE |
| K002644 | Radial Head ImplantKWI · Traditional | 11/20/2000SE |
| K982268 | Ulnar Head ImplantKXE · Traditional | 12/04/1998SE |
Questions and answers
When was Distal Radius Fracture Fixation Plate System cleared by the FDA?
Distal Radius Fracture Fixation Plate System (K990596) received a 510(k) decision of Substantially Equivalent on April 29, 1999, 64 days after the submission was received.
What is the product code of K990596?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.