Cleared Traditional

K2M Expandable Interbody System

K180777 · K2m, Inc. · Orthopedic

Aug 2018

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K180777 is an FDA 510(k) clearance for the K2M Expandable 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 August 3, 2018, 130 days after receiving the submission on March 26, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K180777 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 2018
Decision Date	August 03, 2018
Days to Decision	130 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.