JULIET® LL Lateral Lumbar Cage

Intervertebral Fusion Device With Bone Graft, Lumbar

SPINEART

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

Pre-market Notification Details

• Device ID: K161888
• 510k Number: K161888
• Device Name: JULIET® LL Lateral Lumbar Cage
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215
• Contact: Franck Pennesi
• Correspondent: Franck Pennesi; SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-07-11
• Decision Date: 2016-09-12
• Summary: summary