The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Rialto(tm) Si Fusion System, Medtronic Reusable Instruments For Use With The Ipc(tm) Powerease(tm) System, And Medtronic Navigated Manual Reusable Instruments For Use With The Stealthstation(tm) And Ipc(tm) Powerease(tm) Systems.
| Device ID | K161210 |
| 510k Number | K161210 |
| Device Name: | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments For Use With The IPC(TM) Powerease(TM) System, And Medtronic Navigated Manual Reusable Instruments For Use With The StealthStation(TM) And IPC(TM) Powerease(TM) Systems |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Ankit K. Shah |
| Correspondent | Ankit K. Shah Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | OUR |
| Subsequent Product Code | HWE |
| Subsequent Product Code | OLO |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-28 |
| Decision Date | 2016-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169628977 | K161210 | 000 |
| 00643169628953 | K161210 | 000 |
| 00643169628960 | K161210 | 000 |
| 00643169572546 | K161210 | 000 |
| 00643169571792 | K161210 | 000 |
| 00643169571808 | K161210 | 000 |
| 00643169571815 | K161210 | 000 |
| 00643169571822 | K161210 | 000 |
| 00643169571846 | K161210 | 000 |
| 00643169571860 | K161210 | 000 |
| 00643169572560 | K161210 | 000 |
| 00643169572577 | K161210 | 000 |
| 00643169572584 | K161210 | 000 |