The following data is part of a premarket notification filed by Mako Surgical Corporation with the FDA for Partial Knee Application (pka).
| Device ID | K142530 |
| 510k Number | K142530 |
| Device Name: | Partial Knee Application (PKA) |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale, FL 33317 |
| Contact | Jonathan Reeves |
| Correspondent | Jonathan Reeves MAKO SURGICAL CORPORATION 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 | 2014-09-09 |
| Decision Date | 2015-09-16 |
| Summary: | summary |