Cleared Traditional

icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn? TLIF Lumbar Cage)

K232792 · Icotec AG · Orthopedic

Apr 2024

Decision

207d

Days

Class 2

Risk

About This 510(k) Submission

K232792 is an FDA 510(k) clearance for the icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn? TLIF Lumbar Cage), a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Icotec AG (9450 Altstaetten (Sg), CH). The FDA issued a Cleared decision on April 5, 2024, 207 days after receiving the submission on September 11, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K232792 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2023
Decision Date	April 05, 2024
Days to Decision	207 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.