Cleared Traditional

K131724 - PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE (FDA 510(k) Clearance)

K131724 · Pioneer Surgical Technology, Inc. · Orthopedic device

Dec 2013

Decision

195d

Days

Class 2

Risk

K131724 is an FDA 510(k) clearance for the PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE. This device is classified as 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 FDA review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K131724 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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