The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Total Knee Application (tka).
| Device ID | K143752 |
| 510k Number | K143752 |
| Device Name: | Total Knee Application (TKA) |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MAKO SURGICAL CORP. 2555 DAVIE RD Ft. Lauderdale, FL 33317 |
| Contact | Jonathan Reeves |
| Correspondent | Jonathan Reeves MAKO SURGICAL CORP. 2555 DAVIE RD Ft. 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 | 2014-12-31 |
| Decision Date | 2015-08-06 |
| Summary: | summary |