The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Mako Total Knee Application.
| Device ID | K170581 |
| 510k Number | K170581 |
| Device Name: | Mako Total Knee Application |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MAKO Surgical Corp. 2555 Davie Rd Fort Lauderdale, FL 33317 |
| Contact | Shikha Khandelwal |
| Correspondent | Shikha Khandelwal MAKO Surgical Corp. 2555 Davie Rd Fort Lauderdale, FL 33317 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-28 |
| Decision Date | 2017-05-11 |
| Summary: | summary |