Cleared Traditional

icotec Interbody Cage System

K172480 · Icotec AG · Orthopedic

May 2018

Decision

274d

Days

Class 2

Risk

About This 510(k) Submission

K172480 is an FDA 510(k) clearance for the icotec Interbody Cage System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Icotec AG (9450 Altstaetten (Sg), CH). The FDA issued a Cleared decision on May 17, 2018, 274 days after receiving the submission on August 16, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K172480 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2017
Decision Date	May 17, 2018
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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