Cleared Special

HALF DOME Posterior Lumbar Interbody System

K172947 · Astura Medical · Orthopedic

Apr 2018

Decision

204d

Days

Class 2

Risk

About This 510(k) Submission

K172947 is an FDA 510(k) clearance for the HALF DOME Posterior Lumbar Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Astura Medical (Carlsbad, US). The FDA issued a Cleared decision on April 18, 2018, 204 days after receiving the submission on September 26, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K172947 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2017
Decision Date	April 18, 2018
Days to Decision	204 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.