Cleared Traditional

T2 STRATOSPHERE? Expandable Corpectomy System

K173125 · Medtronic Sofamor Danek · Orthopedic
Dec 2017
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K173125 is an FDA 510(k) clearance for the T2 STRATOSPHERE? Expandable Corpectomy System, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on December 20, 2017, 82 days after receiving the submission on September 29, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K173125 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2017
Decision Date December 20, 2017
Days to Decision 82 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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