Cleared Special

Juliet Ti

K181203 · Spineart · Orthopedic

Jun 2018

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K181203 is an FDA 510(k) clearance for the Juliet Ti, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Spineart (Plan Les Ouates, CH). The FDA issued a Cleared decision on June 28, 2018, 52 days after receiving the submission on May 7, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K181203 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 2018
Decision Date	June 28, 2018
Days to Decision	52 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.