Vu E*Pod Vertebral Body Replacement
FDA 510(k) K071031 · Theken Spine, LLC
510(k) numberK071031
Submission
- Device name
- Vu E*Pod Vertebral Body Replacement
- Applicant
- Theken Spine, LLC
Akron, OH, US - Received
- April 11, 2007
- Decision date
- July 30, 2007
- 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
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| 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 |
|---|---|---|
| K121482 | Instrument System for Endoscopic Spinal SurgeryHRX · Traditional | 08/28/2012SE |
| K121211 | Vu Apod Intervertebral Body Fusion DeviceOVD · Special | 06/27/2012SE |
| K120829 | Stainless Steel Spinal SystemNKB · Special | 05/30/2012SE |
| K120047 | Coral Spinal SystemNKB · Special | 02/03/2012SE |
| K111675 | Vu C*Pod Intervertebral Body Fusion DeviceODP · Special | 08/02/2011SE |
| K103228 | Paramount R Ibf DeviceMAX · Special | 01/05/2011SE |
| K102323 | Cervical Standalone Intervertebral Body Fusion DeviceOVE · Traditional | 12/16/2010SE |
| K101310 | Vu Apod Intervertebral Body Fusion DeviceOVD · Traditional | 09/02/2010SE |
| K100970 | Stainless Steel Spinal SystemNKB · Traditional | 08/12/2010SE |
| K091266 | Theken Coral Spinal SystemNKB · Special | 06/10/2009SE |
Questions and answers
When was Vu E*Pod Vertebral Body Replacement cleared by the FDA?
Vu E*Pod Vertebral Body Replacement (K071031) received a 510(k) decision of Substantially Equivalent on July 30, 2007, 110 days after the submission was received.
What is the product code of K071031?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.