Vista -S Device
FDA 510(k) K070382 · Zimmer Trabecular Metal Technology
510(k) numberK070382
Submission
- Device name
- Vista -S Device
- Applicant
- Zimmer Trabecular Metal Technology
Parsippany, NJ, US - Received
- February 8, 2007
- Decision date
- May 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 |
|---|---|---|
| K133784 | Vista-S Device, Associated InstrumentationODP · Traditional | 07/07/2014SE |
| K123602 | TM Ardis Interbody System InserterMAX · Traditional | 03/01/2013SE |
| K120990 | Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK…MBH · Traditional | 06/29/2012SE |
| K120203 | TM-400 DeviceMAX · Traditional | 06/15/2012SE |
| K113561 | TM Ardis Interbody System TM Ardis Interbody System InstrumenationMAX · Traditional | 05/29/2012SE |
| K111983 | Vista-S Device Model 08/06-401-XXXXX, 08/06-402-XXXXXXODP · Traditional | 11/18/2011SE |
| K103517 | Trabecular Metal Femoral Cone AugmentsMBH · Traditional | 02/15/2011SE |
| K103033 | Trabecular Metal Fusion Device Model 06-101-XXXXX, 06-102-XXXXX and 08-100-XXXXXODP · Traditional | 01/10/2011SE |
| K102896 | Trabecular Metal Tibial Cone AugmentsMBH · Traditional | 12/13/2010SE |
| K093127 | Trabecular Metal (TM) Vertebral Body Replacement (VBR) System Instrument SetMQP · Traditional | 03/04/2010SE |
Questions and answers
When was Vista -S Device cleared by the FDA?
Vista -S Device (K070382) received a 510(k) decision of Substantially Equivalent on May 30, 2007, 111 days after the submission was received.
What is the product code of K070382?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.