The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Restoris Porous Partial Knee System.
| Device ID | K133811 |
| 510k Number | K133811 |
| Device Name: | RESTORIS POROUS PARTIAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer |
| Applicant | MAKO SURGICAL CORP. 575 EIGHTH AVE, SUITE 1212 New York, NY 10018 |
| Contact | Terry Powell |
| Correspondent | Terry Powell MAKO SURGICAL CORP. 575 EIGHTH AVE, SUITE 1212 New York, NY 10018 |
| Product Code | NJD |
| CFR Regulation Number | 888.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-16 |
| Decision Date | 2014-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848486016265 | K133811 | 000 |
| 00848486016128 | K133811 | 000 |
| 00848486016135 | K133811 | 000 |
| 00848486016142 | K133811 | 000 |
| 00848486016159 | K133811 | 000 |
| 00848486016166 | K133811 | 000 |
| 00848486016173 | K133811 | 000 |
| 00848486016180 | K133811 | 000 |
| 00848486016197 | K133811 | 000 |
| 00848486016203 | K133811 | 000 |
| 00848486016210 | K133811 | 000 |
| 00848486016227 | K133811 | 000 |
| 00848486016234 | K133811 | 000 |
| 00848486016241 | K133811 | 000 |
| 00848486016258 | K133811 | 000 |
| 00848486016111 | K133811 | 000 |