The following data is part of a premarket notification filed by Restor3d with the FDA for Restor3d Pin Implants.
| Device ID | K211789 |
| 510k Number | K211789 |
| Device Name: | Restor3d Pin Implants |
| Classification | Pin, Fixation, Smooth |
| Applicant | restor3d 311 W. Corporation St. Durham, NC 27701 |
| Contact | Lexi Lewis |
| Correspondent | Lexi Lewis restor3d 311 W. Corporation St. Durham, NC 27701 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-10 |
| Decision Date | 2022-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840097504667 | K211789 | 000 |
| 00840097504650 | K211789 | 000 |
| 00840097504643 | K211789 | 000 |