Cleared Traditional

Half Dome Posterior Lumbar Interbody System

K152512 · Astura Medical · Orthopedic

Jan 2016

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K152512 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 January 28, 2016, 148 days after receiving the submission on September 2, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K152512 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2015
Decision Date	January 28, 2016
Days to Decision	148 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.