The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Bengal Stackable Cage System.
| Device ID | K190284 |
| 510k Number | K190284 |
| Device Name: | Bengal Stackable Cage System |
| Classification | Spinal Vertebral Body Replacement Device - Cervical |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Linda Bernier |
| Correspondent | Karin Mcdonough DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767 |
| Product Code | PLR |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-11 |
| Decision Date | 2019-12-20 |