Cleared Traditional

UNiD Patient Specific 3D printed cage

K173782 · Medicrea International SA · Orthopedic

Apr 2018

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K173782 is an FDA 510(k) clearance for the UNiD Patient Specific 3D printed 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 April 25, 2018, 133 days after receiving the submission on December 13, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K173782 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2017
Decision Date	April 25, 2018
Days to Decision	133 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.