The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Mako Total Knee Application.
| Device ID | K172219 |
| 510k Number | K172219 |
| Device Name: | Mako Total Knee Application |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MAKO Surgical Corp. 2555 Davie Road Fort Lauderdale, FL 33317 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma MAKO Surgical Corp. 2555 Davie Road Fort Lauderdale, FL 33317 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-24 |
| Decision Date | 2017-09-21 |
| Summary: | summary |