Cleared Special

MOJAVE Expandable Interbody System

K171097 · K2m, Inc. · Orthopedic

May 2017

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K171097 is an FDA 510(k) clearance for the MOJAVE 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 May 10, 2017, 27 days after receiving the submission on April 13, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K171097 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2017
Decision Date	May 10, 2017
Days to Decision	27 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.