The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Si-fix Sacroiliac Joint Fusion System.
| Device ID | K110472 |
| 510k Number | K110472 |
| Device Name: | SI-FIX SACROILIAC JOINT FUSION SYSTEM |
| Classification | Sacroiliac Joint Fixation |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lee Grant |
| Correspondent | Lee Grant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-18 |
| Decision Date | 2012-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169273924 | K110472 | 000 |
| 00643169273900 | K110472 | 000 |
| 00643169273887 | K110472 | 000 |
| 00643169273863 | K110472 | 000 |
| 00643169273849 | K110472 | 000 |