The following data is part of a premarket notification filed by Mako Surgical Corporation with the FDA for Restoris Partial Knee Application (pka), Rio Standard System.
| Device ID | K112507 |
| 510k Number | K112507 |
| Device Name: | RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MAKO SURGICAL CORPORATION 2555 DAVIE ROAD Fort Lauderdale, FL 33317 |
| Contact | Dionne Sanders |
| Correspondent | Dionne Sanders 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 | 2011-08-30 |
| Decision Date | 2012-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848486022211 | K112507 | 000 |
| 00848486007065 | K112507 | 000 |
| 00848486017316 | K112507 | 000 |
| 00848486017200 | K112507 | 000 |
| 00848486000042 | K112507 | 000 |
| 00848486001346 | K112507 | 000 |
| 00848486002664 | K112507 | 000 |
| 00848486002770 | K112507 | 000 |
| 00848486002893 | K112507 | 000 |
| 00848486002909 | K112507 | 000 |
| 00848486002916 | K112507 | 000 |
| 00848486002947 | K112507 | 000 |
| 00848486015879 | K112507 | 000 |
| 00848486017354 | K112507 | 000 |
| 00848486002985 | K112507 | 000 |