Cleared Traditional

DEROYAL SPINE SPACER SYSTEM

K131292 · Deroyal Industries, Inc. · Orthopedic

Feb 2014

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K131292 is an FDA 510(k) clearance for the DEROYAL SPINE SPACER SYSTEM, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Deroyal Industries, Inc. (Chesterland, US). The FDA issued a Cleared decision on February 3, 2014, 273 days after receiving the submission on May 6, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K131292 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2013
Decision Date	February 03, 2014
Days to Decision	273 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.