Cleared Traditional

K120345 - HONOUR SPACER SYSTEM
(FDA 510(k) Clearance)

K120345 · Nexxt Spine, LLC · Orthopedic

Jun 2012

Decision

131d

Days

Class 2

Risk

K120345 is an FDA 510(k) clearance for the HONOUR SPACER SYSTEM. This device is classified as a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP).

Submitted by Nexxt Spine, LLC (Chesterland, US). The FDA issued a Cleared decision on June 13, 2012, 131 days after receiving the submission on February 3, 2012.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..

Submission Details

510(k) Number	K120345 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2012
Decision Date	June 13, 2012
Days to Decision	131 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.