T2 STRATOSPHERE Expandable Corpectomy System
K-Number: K173125 · 2017-12-20
ApplicantMedtronic Sofamor Danek
Decision Date2017-12-20
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
T2 STRATOSPHERE Expandable Corpectomy System is a medical device manufactured by Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2017-12-20 under approval number K173125. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the T2 STRATOSPHERE Expandable Corpectomy System?
T2 STRATOSPHERE Expandable Corpectomy System is a medical device that received FDA 510(k) clearance on 2017-12-20. It is manufactured by Medtronic Sofamor Danek. The 510(k) number is K173125.
When was T2 STRATOSPHERE Expandable Corpectomy System approved by the FDA?
T2 STRATOSPHERE Expandable Corpectomy System received FDA 510(k) clearance on 2017-12-20, under approval number K173125.
What company makes T2 STRATOSPHERE Expandable Corpectomy System?
T2 STRATOSPHERE Expandable Corpectomy System is manufactured by Medtronic Sofamor Danek.
What is the FDA product code for T2 STRATOSPHERE Expandable Corpectomy System?
The FDA product code for T2 STRATOSPHERE Expandable Corpectomy System is MQP.
Related Clinical Trials
Other Devices by Medtronic Sofamor Danek
K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device
K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
K171031CRESCENT Spinal System
K171468FUSE Spinal System
K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
Related Devices (Code: MQP)
K172330Blustone Synergy Silica SystemBlustone Synergy
K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.
K172323Omnia Medical VBROmnia Medical, LLC
K171686Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine
K171704CAPRI Corpectomy Cage SystemK2m
K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.