The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Fortitude Vue Vertebral Body Replacement Device.
| Device ID | K051000 |
| 510k Number | K051000 |
| Device Name: | FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SPINAL CONCEPTS, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Contact | Noah Bartsch |
| Correspondent | Noah Bartsch SPINAL CONCEPTS, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-20 |
| Decision Date | 2005-05-19 |
| Summary: | summary |