The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Concorde Bullet Spinal System.
| Device ID | K151352 |
| 510k Number | K151352 |
| Device Name: | CONCORDE Bullet Spinal System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38 Le Locle, CH 2400 |
| Contact | Jeffrey Shiffman |
| Correspondent | Jeffrey Shiffman 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-20 |
| Decision Date | 2015-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034454283 | K151352 | 000 |
| 10705034454429 | K151352 | 000 |
| 10705034454436 | K151352 | 000 |
| 10705034454443 | K151352 | 000 |
| 10705034454450 | K151352 | 000 |
| 10705034454467 | K151352 | 000 |
| 10705034454474 | K151352 | 000 |
| 10705034454481 | K151352 | 000 |
| 10705034454498 | K151352 | 000 |
| 10705034454412 | K151352 | 000 |
| 10705034454405 | K151352 | 000 |
| 10705034454399 | K151352 | 000 |
| 10705034454290 | K151352 | 000 |
| 10705034454320 | K151352 | 000 |
| 10705034454337 | K151352 | 000 |
| 10705034454344 | K151352 | 000 |
| 10705034454351 | K151352 | 000 |
| 10705034454368 | K151352 | 000 |
| 10705034454375 | K151352 | 000 |
| 10705034454382 | K151352 | 000 |
| 10705034454504 | K151352 | 000 |
| 10705034454511 | K151352 | 000 |
| 10705034454634 | K151352 | 000 |
| 10705034454641 | K151352 | 000 |
| 10705034454658 | K151352 | 000 |
| 10705034454665 | K151352 | 000 |
| 10705034454672 | K151352 | 000 |
| 10705034454689 | K151352 | 000 |
| 10705034454696 | K151352 | 000 |
| 10705034454702 | K151352 | 000 |
| 10705034454627 | K151352 | 000 |
| 10705034454610 | K151352 | 000 |
| 10705034454603 | K151352 | 000 |
| 10705034454528 | K151352 | 000 |
| 10705034454535 | K151352 | 000 |
| 10705034454542 | K151352 | 000 |
| 10705034454559 | K151352 | 000 |
| 10705034454566 | K151352 | 000 |
| 10705034454573 | K151352 | 000 |
| 10705034454580 | K151352 | 000 |
| 10705034454597 | K151352 | 000 |
| 10705034454719 | K151352 | 000 |