Cleared Traditional

INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM

K051821 · Inion , Ltd. · Orthopedic

Nov 2005

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K051821 is an FDA 510(k) clearance for the INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, a Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate (Class II — Special Controls, product code OJB), submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on November 25, 2005, 143 days after receiving the submission on July 5, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K051821 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2005
Decision Date	November 25, 2005
Days to Decision	143 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.