The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Concorde Lift.
| Device ID | K171425 |
| 510k Number | K171425 |
| Device Name: | CONCORDE LIFT |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Karen Sylvia |
| Correspondent | Desiree Saracino Depuy Synthes 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 | 2017-05-15 |
| Decision Date | 2017-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034531601 | K171425 | 000 |
| 10705034531595 | K171425 | 000 |
| 10705034531588 | K171425 | 000 |
| 10705034531571 | K171425 | 000 |
| 10705034531564 | K171425 | 000 |
| 10705034531557 | K171425 | 000 |
| 10705034531540 | K171425 | 000 |
| 10705034531526 | K171425 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CONCORDE LIFT 87235871 5509251 Live/Registered |
DePuy Synthes, Inc. 2016-11-14 |