DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
FDA 510(k) K233665 · DePuy Synthes
510(k) numberK233665
Submission
- Device name
- DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
- Applicant
- DePuy Synthes
West Chester, PA, US - Received
- November 15, 2023
- Decision date
- March 21, 2024
- 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 |
|---|---|---|
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced SystemHSB · Traditional | 08/01/2024SE |
| K233256 | Robotic Integration InstrumentsOLO · Traditional | 06/17/2024SE |
| K233255 | CROSSNAV Navigation Enabled InstrumentsOLO · Traditional | 06/17/2024SE |
| K233254 | TELIGEN System Navigation Ready InstrumentsOLO · Traditional | 06/14/2024SE |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemKTT · Special | 07/26/2023SE |
| K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular SystemHRS · Traditional | 09/20/2022SE |
| K213563 | DePuy Synthes Radial Head Replacement SystemKWI · Traditional | 03/18/2022SE |
| K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)HRS · Traditional | 06/02/2021SE |
| K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle…HRS · Special | 12/16/2020SE |
| K201959 | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate SystemHRS · Traditional | 09/11/2020SE |
Questions and answers
When was DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System cleared by the FDA?
DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System (K233665) received a 510(k) decision of Substantially Equivalent on March 21, 2024, 127 days after the submission was received.
What is the product code of K233665?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.