Cleared Traditional

CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC

K133455 · Pioneer Surgical Technology, Inc. · Orthopedic

Mar 2014

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K133455 is an FDA 510(k) clearance for the CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC, 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 March 27, 2014, 135 days after receiving the submission on November 12, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K133455 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2013
Decision Date	March 27, 2014
Days to Decision	135 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.