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 |