The following data is part of a premarket notification filed by Mako Surgical Corporation with the FDA for Makoplasty Total Hip Allpication, Rio Standard System.
| Device ID | K141989 |
| 510k Number | K141989 |
| Device Name: | MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-22 |
| Decision Date | 2014-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848486032135 | K141989 | 000 |
| 00848486028091 | K141989 | 000 |
| 00848486028084 | K141989 | 000 |
| 00848486028077 | K141989 | 000 |
| 00848486028060 | K141989 | 000 |
| 00848486028053 | K141989 | 000 |
| 00848486028046 | K141989 | 000 |
| 00848486023010 | K141989 | 000 |
| 00848486021832 | K141989 | 000 |
| 00848486017194 | K141989 | 000 |
| 00848486028107 | K141989 | 000 |
| 00848486028114 | K141989 | 000 |
| 00848486030964 | K141989 | 000 |
| 00848486030957 | K141989 | 000 |
| 00848486030322 | K141989 | 000 |
| 00848486030315 | K141989 | 000 |
| 00848486030308 | K141989 | 000 |
| 00848486030285 | K141989 | 000 |
| 00848486030278 | K141989 | 000 |
| 00848486028138 | K141989 | 000 |
| 00848486028121 | K141989 | 000 |
| 00848486017187 | K141989 | 000 |