Juliet® Ti LL Lumbar Interbody Device

Intervertebral Fusion Device With Integrated Fixation, Lumbar

SPINEART

The following data is part of a premarket notification filed by Spineart with the FDA for Juliet® Ti Ll Lumbar Interbody Device.

Pre-market Notification Details

• Device ID: K190877
• 510k Number: K190877
• Device Name: Juliet® Ti LL Lumbar Interbody Device
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: SPINEART 3 Chemin Du Pre Fleuri Plan Ouates, CH 1228
• Contact: Franck Pennesi
• Correspondent: Franck Pennesi; SPINEART 3 Chemin Du Pre Fleuri Plan Ouates, CH 1228
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-04
• Decision Date: 2019-05-29