K080029 is an FDA 510(k) clearance for the MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM. This device is classified as a Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code KRR).
Submitted by Mako Surgical Corp. (Ft. Lauderdale, US). The FDA issued a Cleared decision on May 16, 2008, 133 days after receiving the submission on January 4, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3540.
| 510(k) Number | K080029 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 2008 |
| Decision Date | May 16, 2008 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KRR — Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3540 |