The following data is part of a premarket notification filed by Mako Surgical Corporation with the FDA for Restoris Porous Partial Knee System.
| Device ID | K150410 |
| 510k Number | K150410 |
| Device Name: | RESTORIS POROUS PARTIAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale, FL 33317 |
| Contact | Jonathan Reeves |
| Correspondent | Jonathan Reeves MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale, FL 33317 |
| Product Code | HRY |
| Subsequent Product Code | NJD |
| Subsequent Product Code | OIY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-03-20 |
| Summary: | summary |