Vertebron VBR System
FDA 510(k) K073502 · Vertebron, Inc.
510(k) numberK073502
Submission
- Device name
- Vertebron VBR System
- Applicant
- Vertebron, Inc.
Stratford, CT, US - Received
- December 13, 2007
- Decision date
- March 24, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
More from Corelink, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K081567 | Vertebron SSP Cervical Plating SystemKWQ · Special | 07/03/2008SE |
| K081597 | Modification to Vertebron PSS Pedicle Screw SystemMNI · Special | 07/02/2008SE |
| K071376 | Modification to Vertebron PSS Pedicle Screw SystemNKB · Special | 06/13/2007SE |
| K062110 | Vertebron SCP Cervical Plate SystemKWQ · Special | 08/16/2006SE |
| K051815 | Modification to Vertebron SCP Cervical Plate SystemKWQ · Special | 10/17/2005SE |
| K051716 | Vertebron PSS Pedicle Screw SystemKWP · Special | 09/07/2005SE |
| K043152 | Vertebron PSS Pedicle Screw SystemMNH · Special | 02/01/2005SE |
| K043181 | Modification to Vertebron SCP Cervical Plate SystemKWQ · Special | 12/17/2004SE |
| K040003 | Vertebron SCP Cervical Plate SystemKWQ · Traditional | 03/26/2004SE |
| K033352 | Vertebron PSS Pedicle Screw SystemMNI · Traditional | 02/25/2004SE |
Questions and answers
When was Vertebron VBR System cleared by the FDA?
Vertebron VBR System (K073502) received a 510(k) decision of Substantially Equivalent on March 24, 2008, 102 days after the submission was received.
What is the product code of K073502?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.