The following data is part of a premarket notification filed by Zimmer Trabecular with the FDA for Vista P Vertebral Body Replacement System.
| Device ID | K061155 |
| 510k Number | K061155 |
| Device Name: | VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Contact | Robert A Poggie |
| Correspondent | Robert A Poggie ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-26 |
| Decision Date | 2006-09-22 |
| Summary: | summary |