The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Conduit Instruments.
Device ID | K210728 |
510k Number | K210728 |
Device Name: | CONDUIT Instruments |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400 |
Contact | Christine Cahillane |
Correspondent | Christine Cahillane DePuy Spine 325 Paramount Dr. 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 | 2021-03-11 |
Decision Date | 2021-05-06 |