TSolution One W/ACG+ 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 W/acg+ Surgical System.

Pre-market Notification Details

Device IDK153647
510k NumberK153647
Device Name:TSolution One W/ACG+ 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-21
Decision Date2016-02-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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M9461005730 K153647 000

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