The following data is part of a premarket notification filed by Met One Technologies with the FDA for Audere Lumbar Spacer System.
| Device ID | K193457 |
| 510k Number | K193457 |
| Device Name: | AUDERE Lumbar Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Met One Technologies 513 W. San Antonio Ave, Suite C El Paso, TX 79901 |
| Contact | Kyle Atwood |
| Correspondent | Evan Carbonell Met One Technologies 513 W. San Antonio Ave, Suite C El Paso, TX 79901 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-05-12 |