The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Firebird Si Fusion System.
| Device ID | K201664 |
| 510k Number | K201664 |
| Device Name: | FIREBIRD SI Fusion System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056 |
| Contact | Jacki Koch |
| Correspondent | Jacki Koch Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-19 |
| Decision Date | 2020-09-15 |