The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Conduit Lateral Switch Plate.
| Device ID | K221325 |
| 510k Number | K221325 |
| Device Name: | CONDUIT Lateral Switch Plate |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | LiJuan He |
| Correspondent | LiJuan He DePuy Spine 325 Paramount Dr. Raynham, MA 02767 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-06 |
| Decision Date | 2022-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034574981 | K221325 | 000 |
| 10705034574639 | K221325 | 000 |
| 10705034574622 | K221325 | 000 |
| 10705034574608 | K221325 | 000 |
| 10705034574592 | K221325 | 000 |
| 10705034574585 | K221325 | 000 |
| 10705034574578 | K221325 | 000 |
| 10705034574561 | K221325 | 000 |
| 10705034574554 | K221325 | 000 |
| 10705034574547 | K221325 | 000 |
| 10705034574530 | K221325 | 000 |
| 10705034574646 | K221325 | 000 |
| 10705034574653 | K221325 | 000 |
| 10705034574882 | K221325 | 000 |
| 10705034574875 | K221325 | 000 |
| 10705034574868 | K221325 | 000 |
| 10705034574851 | K221325 | 000 |
| 10705034574837 | K221325 | 000 |
| 10705034574820 | K221325 | 000 |
| 10705034574813 | K221325 | 000 |
| 10705034574806 | K221325 | 000 |
| 10705034574745 | K221325 | 000 |
| 10705034574684 | K221325 | 000 |
| 10705034574523 | K221325 | 000 |