Cleared Traditional

ALTA Anterior Cervical Interbody Spacer

K160154 · Astura Medical · Orthopedic

May 2016

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K160154 is an FDA 510(k) clearance for the ALTA Anterior Cervical Interbody Spacer, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Astura Medical (Carlsbad, US). The FDA issued a Cleared decision on May 13, 2016, 114 days after receiving the submission on January 20, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K160154 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 20, 2016
Decision Date	May 13, 2016
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.