The following data is part of a premarket notification filed by Restor3d with the FDA for Restor3d Tidal Lumbar Interbody Fusion Device.
| Device ID | K220523 |
| 510k Number | K220523 |
| Device Name: | Restor3d TiDAL Lumbar Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Restor3d 404 Hunt St. Suite 500 Durham, NC 27701 |
| Contact | Shyam Patel |
| Correspondent | Shyam Patel Restor3d 404 Hunt St. Suite 500 Durham, NC 27701 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-23 |
| Decision Date | 2022-06-17 |