The following data is part of a premarket notification filed by Spineart with the FDA for Juliet Ti Ll.
Device ID | K173702 |
510k Number | K173702 |
Device Name: | Juliet Ti LL |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | SPINEART 3 Chemin Du Pre Fleuri Plan Les Ouates, CH 1228 |
Contact | Franck Pennesi |
Correspondent | Franck Pennesi SPINEART 3 Chemin Du Pre Fleuri Plan Les Ouates, CH 1228 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-04 |
Decision Date | 2018-01-03 |
Summary: | summary |