The following data is part of a premarket notification filed by Restor3d with the FDA for Restor3d Metallic Interference Screw.
| Device ID | K193491 |
| 510k Number | K193491 |
| Device Name: | Restor3d Metallic Interference Screw |
| Classification | Screw, Fixation, Bone |
| Applicant | restor3D 311 W Corporation St Durham, NC 27701 |
| Contact | Nathan Evans |
| Correspondent | Nathan Evans restor3D 311 W Corporation St Durham, NC 27701 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-17 |
| Decision Date | 2020-03-19 |