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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18257200140114 | K183342 | 000 |
| 18257200140138 | K183342 | 000 |
| 18257200140145 | K183342 | 000 |
| 18257200140152 | K183342 | 000 |
| 18257200140169 | K183342 | 000 |
| 18257200140176 | K183342 | 000 |
| 18257200140183 | K183342 | 000 |
| 18257200140190 | K183342 | 000 |
| 18257200140206 | K183342 | 000 |
| 18257200140213 | K183342 | 000 |
| 18257200140220 | K183342 | 000 |
| 18257200140237 | K183342 | 000 |
| 18257200140244 | K183342 | 000 |
| 18257200140251 | K183342 | 000 |
| 18257200140268 | K183342 | 000 |
| 18257200140275 | K183342 | 000 |
| 18257200140107 | K183342 | 000 |
| 18257200140121 | K183342 | 000 |