Cleared Traditional

SAHARA Stabilization System

K190179 · K2m, Inc. · Orthopedic

Oct 2019

Decision

244d

Days

Class 2

Risk

About This 510(k) Submission

K190179 is an FDA 510(k) clearance for the SAHARA Stabilization System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on October 3, 2019, 244 days after receiving the submission on February 1, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K190179 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2019
Decision Date	October 03, 2019
Days to Decision	244 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.