The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Sambascrew 3d Si Fusion System.
| Device ID | K183342 |
| 510k Number | K183342 |
| Device Name: | SambaScrew 3D 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 | 2018-12-03 |
| Decision Date | 2019-04-30 |