Cleared Traditional

Cascadia Interbody System

K172009 · K2m, Inc. · Orthopedic

Dec 2017

Decision

164d

Days

Class 2

Risk

About This 510(k) Submission

K172009 is an FDA 510(k) clearance for the Cascadia Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on December 14, 2017, 164 days after receiving the submission on July 3, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K172009 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2017
Decision Date	December 14, 2017
Days to Decision	164 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.