Cleared Special

Cascadia Interbody System

K162264 · K2m, Inc. · Orthopedic

Sep 2016

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K162264 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 September 21, 2016, 41 days after receiving the submission on August 11, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K162264 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2016
Decision Date	September 21, 2016
Days to Decision	41 days
Submission Type	Special
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.