Cleared Traditional

Inion Spinal Graft Containment System

K151360 · Inion OY · Orthopedic
Oct 2015
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K151360 is an FDA 510(k) clearance for the Inion Spinal Graft Containment System, a Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate (Class II — Special Controls, product code OJB), submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on October 6, 2015, 139 days after receiving the submission on May 20, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K151360 FDA.gov
FDA Decision Cleared SESU
Date Received May 20, 2015
Decision Date October 06, 2015
Days to Decision 139 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OJB — Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060
Definition Maintain Position Of Bone Graft In Spinal Fusion Procedures. Intended For Use In Spinal Fusion Procedures As A Means To Maintain The Relative Position Of Weak Bony Tissue Such As Allografts Or Autografts, In Conjunction With Traditional Rigid Fixation.