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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K210668
Device Name TSolution One Total Knee Application
Applicant
THINK Surgical, Inc.
47201 Lakeview Blvd.
Fremont,  CA  94538
Applicant Contact Meliha Mulalic
Correspondent
THINK Surgical, Inc.
47201 Lakeview Blvd.
Fremont,  CA  94538
Correspondent Contact Meliha Mulalic
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/05/2021
Decision Date 04/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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