Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K150307
RESTORIS Multicompartmental Knee System · Mako Surgical Corp. · decided 2015-03-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Mako | 180735-5 | MAKO SURGICAL CORP. | HRY HSX KRR NJD NPJ OIY | 00848486016586 |
| RESTORIS | 180708-3 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486001025 |
| RESTORIS | 180518 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486000677 |
| Mako | 180734-3 | MAKO SURGICAL CORP. | HRY HSX KRR NJD NPJ OIY | 00848486016517 |
| Mako | 180737-3 | MAKO SURGICAL CORP. | HRY HSX KRR NJD NPJ OIY | 00848486016661 |
| Mako | 180738-3 | MAKO SURGICAL CORP. | HRY HSX KRR NJD NPJ OIY | 00848486016715 |
| RESTORIS | 180703-5 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486002176 |
| RESTORIS | 180701-4 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486002046 |
| RESTORIS | 180603 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486000691 |
| RESTORIS | 180707-9 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486002459 |
| RESTORIS | 180501 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486001438 |
| RESTORIS | 180402 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486000400 |
| RESTORIS | 180614 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486000776 |
| RESTORIS | 180507 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486000592 |
| RESTORIS | 180705-5 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486002299 |
| Mako | 180737-1 | MAKO SURGICAL CORP. | HRY HSX KRR NJD NPJ OIY | 00848486016647 |
| RESTORIS | 180704-7 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486002251 |
| Mako | 180732-2 | MAKO SURGICAL CORP. | HRY HSX KRR NJD NPJ OIY | 00848486016401 |
| RESTORIS | 180701-6 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486002060 |
| RESTORIS | 180708-8 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486002503 |
| RESTORIS | 180707-7 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486002435 |
| RESTORIS | 180601 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486001995 |
| RESTORIS | 180707-1 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486000974 |
| Mako | 180731-2 | MAKO SURGICAL CORP. | HRY HSX KRR NJD NPJ OIY | 00848486016357 |
| RESTORIS | 180703-8 | MAKO SURGICAL CORP. | HRY HSX KRR NPJ | 00848486002206 |