The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Mako Surgical Corp. Patellofemoral Knee Implant System.
| Device ID | K080029 |
| 510k Number | K080029 |
| Device Name: | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Applicant | MAKO SURGICAL CORP. 2555 DAVIE RD., SUITE 110 Ft. Lauderdale, FL 33317 |
| Contact | William F Tapia |
| Correspondent | William F Tapia MAKO SURGICAL CORP. 2555 DAVIE RD., SUITE 110 Ft. Lauderdale, FL 33317 |
| Product Code | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-04 |
| Decision Date | 2008-05-16 |
| Summary: | summary |