Cleared Traditional

K160958 - Battalion Universal Spacer System
(FDA 510(k) Clearance)

K160958 · Alphatec Spine · Orthopedic
Sep 2016
Decision
156d
Days
Class 2
Risk

K160958 is an FDA 510(k) clearance for the Battalion Universal Spacer System, a Intervertebral Fusion Device With Bone Graft, Thoracic (Class II — Special Controls, product code PHM), submitted by Alphatec Spine (Carlsnad, US). The FDA issued a Cleared decision on September 8, 2016, 156 days after receiving the submission on April 5, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number K160958 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2016
Decision Date September 08, 2016
Days to Decision 156 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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