MIS Spine Frame Instrument Case

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

THOMPSON SURGICAL INSTRUMENTS

The following data is part of a premarket notification filed by Thompson Surgical Instruments with the FDA for Mis Spine Frame Instrument Case.

Pre-market Notification Details

Device IDK151347
510k NumberK151347
Device Name:MIS Spine Frame Instrument Case
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant THOMPSON SURGICAL INSTRUMENTS 10170 E CHERRY BEND RD Traverse City,  MI  49684
ContactStephanie Myers
CorrespondentStephanie Myers
THOMPSON SURGICAL INSTRUMENTS 10170 E CHERRY BEND RD Traverse City,  MI  49684
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-20
Decision Date2015-10-16
Summary:summary

NIH GUDID Devices

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