Cleared Special

PIONEER CROSSFUSE II IBF/VBR SYSTEM

K112496 · Pioneer Surgical Technology, Inc. · Orthopedic

Sep 2011

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K112496 is an FDA 510(k) clearance for the PIONEER CROSSFUSE II IBF/VBR SYSTEM, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on September 28, 2011, 30 days after receiving the submission on August 29, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K112496 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2011
Decision Date	September 28, 2011
Days to Decision	30 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.