Cleared Traditional

UNiD Patient specific 3D printed TLIF cage

K190092 · Medicrea International SA · Orthopedic

May 2019

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K190092 is an FDA 510(k) clearance for the UNiD Patient specific 3D printed TLIF cage, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Medicrea International SA (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on May 8, 2019, 110 days after receiving the submission on January 18, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K190092 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 2019
Decision Date	May 08, 2019
Days to Decision	110 days
Submission Type	Traditional
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.