TSolution® One Total Knee Application

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 Total Knee Application.

Pre-market Notification Details

Device IDK201255
510k NumberK201255
Device Name:TSolution® One Total Knee Application
ClassificationOrthopedic Stereotaxic Instrument
Applicant THINK Surgical, Inc. 47201 Lakeview Blvd Fremont,  CA  94538
ContactMeliha Mulalic
CorrespondentMeliha Mulalic
THINK Surgical, Inc. 47201 Lakeview Blvd Fremont,  CA  94538
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-11
Decision Date2020-06-10

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.