Surgical Navigation Advanced Platform (SNAP)

System, Image Processing, Radiological

SURGICAL THEATER, LLC

The following data is part of a premarket notification filed by Surgical Theater, Llc with the FDA for Surgical Navigation Advanced Platform (snap).

Pre-market Notification Details

Device IDK160584
510k NumberK160584
Device Name:Surgical Navigation Advanced Platform (SNAP)
ClassificationSystem, Image Processing, Radiological
Applicant SURGICAL THEATER, LLC 781 BETA DR. Mayfield Village,  OH  44143
ContactKevin Murrock
CorrespondentKevin Murrock
SURGICAL THEATER, LLC 781 BETA DR. Mayfield Village,  OH  44143
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-01
Decision Date2016-06-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00863157000374 K160584 000
00863157000367 K160584 000
00863157000329 K160584 000
00863157000312 K160584 000
00860003884102 K160584 000
00863157000305 K160584 000

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