The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Restoris Multicompartmental Knee System.
| Device ID | K150307 |
| 510k Number | K150307 |
| Device Name: | RESTORIS Multicompartmental Knee System |
| Classification | Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MAKO SURGICAL CORP. 2555 DAVIE RD. Ft. Lauderdale, FL 33317 |
| Contact | Jonathan Reeves |
| Correspondent | Jonathan Reeves MAKO SURGICAL CORP. 2555 DAVIE RD. Ft. Lauderdale, FL 33317 |
| Product Code | NPJ |
| Subsequent Product Code | HRY |
| Subsequent Product Code | HSX |
| Subsequent Product Code | KRR |
| Subsequent Product Code | OIY |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848486016739 | K150307 | 000 |
| 00848486016517 | K150307 | 000 |
| 00848486016500 | K150307 | 000 |
| 00848486016494 | K150307 | 000 |
| 00848486016487 | K150307 | 000 |
| 00848486016463 | K150307 | 000 |
| 00848486016456 | K150307 | 000 |
| 00848486016449 | K150307 | 000 |
| 00848486016432 | K150307 | 000 |
| 00848486016418 | K150307 | 000 |
| 00848486016401 | K150307 | 000 |
| 00848486016395 | K150307 | 000 |
| 00848486016388 | K150307 | 000 |
| 00848486016364 | K150307 | 000 |
| 00848486016357 | K150307 | 000 |
| 00848486016531 | K150307 | 000 |
| 00848486016548 | K150307 | 000 |
| 00848486016715 | K150307 | 000 |
| 00848486016708 | K150307 | 000 |
| 00848486016692 | K150307 | 000 |
| 00848486016685 | K150307 | 000 |
| 00848486016661 | K150307 | 000 |
| 00848486016654 | K150307 | 000 |
| 00848486016647 | K150307 | 000 |
| 00848486016630 | K150307 | 000 |
| 00848486016616 | K150307 | 000 |
| 00848486016609 | K150307 | 000 |
| 00848486016593 | K150307 | 000 |
| 00848486016586 | K150307 | 000 |
| 00848486016562 | K150307 | 000 |
| 00848486016555 | K150307 | 000 |
| 00848486016340 | K150307 | 000 |