Medtronic Transportation/Sterilization Cassettes

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Medtronic Sofamor Danek USA, Inc.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Medtronic Transportation/sterilization Cassettes.

Pre-market Notification Details

Device IDK152241
510k NumberK152241
Device Name:Medtronic Transportation/Sterilization Cassettes
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactVictoria Scheitlin
CorrespondentVictoria Scheitlin
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-10
Decision Date2016-01-20
Summary:summary

NIH GUDID Devices

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