The following data is part of a premarket notification filed by Si-bone, Inc. with the FDA for Si Joint Fusion System.
| Device ID | K080398 |
| 510k Number | K080398 |
| Device Name: | SI JOINT FUSION SYSTEM |
| Classification | Sacroiliac Joint Fixation |
| Applicant | SI-BONE, INC. 15370 PEPPER LANE Saratoga, CA 95070 |
| Contact | Jeffery Dunn |
| Correspondent | Jeffery Dunn SI-BONE, INC. 15370 PEPPER LANE Saratoga, CA 95070 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-13 |
| Decision Date | 2008-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420148858 | K080398 | 000 |
| 00840420148438 | K080398 | 000 |
| 00840420145741 | K080398 | 000 |
| 00840420145734 | K080398 | 000 |
| 00840420145727 | K080398 | 000 |
| 00840420145710 | K080398 | 000 |