The following data is part of a premarket notification filed by Restor3d, Inc. with the FDA for Restor3d Mtp Implant.
| Device ID | K201393 |
| 510k Number | K201393 |
| Device Name: | Restor3d MTP Implant |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | Restor3d, Inc. 311 W Corporation St Durham, NC 27701 |
| Contact | Nathan Evans |
| Correspondent | Jillian Udell Restor3d, Inc. 311 W Corporation St Durham, NC 27701 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-27 |
| Decision Date | 2022-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840097505244 | K201393 | 000 |
| 00840097505237 | K201393 | 000 |
| 00840097505220 | K201393 | 000 |