The following data is part of a premarket notification filed by Additive Device, Inc. (adi) D/b/a Restor3d with the FDA for Adi Tidal Osteotomy Wedge.
| Device ID | K191047 |
| 510k Number | K191047 |
| Device Name: | ADI TiDAL Osteotomy Wedge |
| Classification | Bone Wedge |
| Applicant | Additive Device, Inc. (ADI) D/b/a Restor3d 311 W Corporation St. Durham, NC 27701 |
| Contact | Nathan Evans |
| Correspondent | Nathan Evans Additive Device, Inc. (ADI) D/b/a Restor3d 311 W Corporation St. Durham, NC 27701 |
| Product Code | PLF |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-19 |
| Decision Date | 2019-11-05 |