The following data is part of a premarket notification filed by Mako Surgical Corporation with the FDA for Restoris Multicompartmental Knee (mck) System.
| Device ID | K090763 |
| 510k Number | K090763 |
| Device Name: | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM |
| Classification | Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale, FL 33317 |
| Contact | William F Tapia |
| Correspondent | William F Tapia MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale, FL 33317 |
| Product Code | NPJ |
| Subsequent Product Code | HRY |
| Subsequent Product Code | HSX |
| Subsequent Product Code | KRR |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-23 |
| Decision Date | 2009-06-17 |
| Summary: | summary |