The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Mako Surgical Unicondylar Knee System.
| Device ID | K060017 |
| 510k Number | K060017 |
| Device Name: | MAKO SURGICAL UNICONDYLAR KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | MAKO SURGICAL CORP. 2901 SIMMS STREET Hollywood, FL 33020 |
| Contact | William F Tapia |
| Correspondent | William F Tapia MAKO SURGICAL CORP. 2901 SIMMS STREET Hollywood, FL 33020 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-04 |
| Decision Date | 2006-02-23 |
| Summary: | summary |