Quantum Vertebral Body Replacement
FDA 510(k) K050449 · Quantum Orthopedics, Inc.
510(k) numberK050449
Submission
- Device name
- Quantum Vertebral Body Replacement
- Applicant
- Quantum Orthopedics, Inc.
Carlsbad, CA, US - Received
- February 22, 2005
- Decision date
- July 7, 2005
- 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 |
|---|---|---|
| K062004 | Modification to Quantum Vertebral Body ReplacementMQP · Special | 08/15/2006SE |
| K061576 | Modification to Quantum Vertebral Body Replacement SystemMQP · Special | 07/03/2006SE |
| K052641 | Modification to: Quantum Vertebral Body ReplacementMQP · Special | 04/12/2006SE |
| K060491 | Quantum Anterior Cervical Plate SystemKWQ · Traditional | 03/13/2006SE |
| K040276 | Quantum Cement RestrictorJDK · Traditional | 04/30/2004SE |
Questions and answers
When was Quantum Vertebral Body Replacement cleared by the FDA?
Quantum Vertebral Body Replacement (K050449) received a 510(k) decision of Substantially Equivalent on July 7, 2005, 135 days after the submission was received.
What is the product code of K050449?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.