The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Concorde Bullet Lumbar Interbody System.
| Device ID | K151773 |
| 510k Number | K151773 |
| Device Name: | CONCORDE Bullet Lumbar Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medos International, Sarl Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Jaclyn Porsolt |
| Correspondent | Jaclyn Porsolt DePuy Spine, A Johnson & Johnson Company 325 Paramount Drive 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 | 2015-06-30 |
| Decision Date | 2015-11-20 |
| Summary: | summary |