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 |