The following data is part of a premarket notification filed by Zimmer Trabecular Metal Technology with the FDA for Vista-s Device Model 08/06-401-xxxxx, 08/06-402-xxxxxx.
| Device ID | K111983 |
| 510k Number | K111983 |
| Device Name: | VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
| Contact | Kathleen Rutherford |
| Correspondent | Kathleen Rutherford ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-12 |
| Decision Date | 2011-11-18 |
| Summary: | summary |