The following data is part of a premarket notification filed by Spinal Usa with the FDA for Vault Alif System.
| Device ID | K103369 |
| 510k Number | K103369 |
| Device Name: | VAULT ALIF SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208 |
| Contact | Linda Polk |
| Correspondent | Linda Polk SPINAL USA 2050 EXECUTIVE DR. Pearl, MS 39208 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-17 |
| Decision Date | 2011-04-04 |
| Summary: | summary |