The following data is part of a premarket notification filed by Stryker Spine with the FDA for Vlift-s Vertebral Body Replacement System, Models 488812xx, 488814xx, 488816xx, 488818xx.
| Device ID | K091946 |
| 510k Number | K091946 |
| Device Name: | VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Kimberly Lane |
| Correspondent | Kimberly Lane STRYKER SPINE 2 PEARL COURT 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 | 2009-06-30 |
| Decision Date | 2009-09-25 |
| Summary: | summary |