Cleared Traditional

PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE

K131724 · Pioneer Surgical Technology, Inc. · Orthopedic
Dec 2013
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K131724 is an FDA 510(k) clearance for the PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on December 24, 2013, 195 days after receiving the submission on June 12, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K131724 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2013
Decision Date December 24, 2013
Days to Decision 195 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQP — Spinal Vertebral Body Replacement Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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