The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Restoris Multi-compartmental Knee System.
| Device ID | K220930 |
| 510k Number | K220930 |
| Device Name: | Restoris Multi-Compartmental Knee System |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | Mako Surgical Corp. 3365 Enterprise Ave Weston, FL 33331 |
| Contact | Emily DiMambro |
| Correspondent | Emily DiMambro Mako Surgical Corp. 3365 Enterprise Ave Weston, FL 33331 |
| Product Code | HSX |
| Subsequent Product Code | HRY |
| Subsequent Product Code | KRR |
| Subsequent Product Code | NPJ |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-31 |
| Decision Date | 2022-06-02 |