Vista P Vertebral Body Replacement System
FDA 510(k) K061155 · Zimmer Trabecular
510(k) numberK061155
Submission
- Device name
- Vista P Vertebral Body Replacement System
- Applicant
- Zimmer Trabecular
Allendale, NJ, US - Received
- April 26, 2006
- Decision date
- September 22, 2006
- 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
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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 |
|---|---|---|
| K061067 | Trabecular Metal Acetabular AugmentsLPH · Traditional | 05/25/2006SE |
| K053340 | Trabecular Metal Tibial and Femoral Cone AugmentsMBH · Traditional | 02/27/2006SE |
| K052950 | The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemMQP · Special | 11/16/2005SE |
| K051756 | Modification To:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZJWH · Special | 07/27/2005SE |
| K050766 | Explant Osteonecrosis Intervention Implant Removal SystemHWE · Traditional | 05/26/2005SE |
| K050937 | Trabecular Metal Acetabular Revision ShellsLPH · Special | 05/11/2005SE |
| K050101 | The Trabecular Metal Bone Stabilization Implant, Model 99-11197-XX-10HRS · Traditional | 04/15/2005SE |
| K042871 | Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3…LPH · Special | 12/21/2004SE |
| K043061 | The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Model…KWS · Special | 11/23/2004SE |
Questions and answers
When was Vista P Vertebral Body Replacement System cleared by the FDA?
Vista P Vertebral Body Replacement System (K061155) received a 510(k) decision of Substantially Equivalent on September 22, 2006, 149 days after the submission was received.
What is the product code of K061155?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.