TSolution One Cup1 Surgical System

Orthopedic Stereotaxic Instrument

THINK SURGICAL INC.

The following data is part of a premarket notification filed by Think Surgical Inc. with the FDA for Tsolution One Cup1 Surgical System.

Pre-market Notification Details

Device IDK162195
510k NumberK162195
Device Name:TSolution One Cup1 Surgical System
ClassificationOrthopedic Stereotaxic Instrument
Applicant THINK SURGICAL INC. 47320 MISSION FALLS COURT Fremont,  CA  94539
ContactIn K. Mun
CorrespondentGlen Emelock
THE CRO GROUP, INC. 32 HARRISON ST. Melrose,  MA  02176
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-05
Decision Date2016-09-14
Summary:summary

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