The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Axtiha Stand-alone Alif System.
| Device ID | K212967 |
| 510k Number | K212967 |
| Device Name: | AxTiHA Stand-Alone ALIF System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 |
| Contact | Marshall Mccarty |
| Correspondent | Marshall Mccarty Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-16 |
| Decision Date | 2021-10-15 |