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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Computer Controlled Surgical System
510(k) Number K150741
Device Name TSolution One w/ACG surgical System
Applicant
THINK Surgical, Inc.
47320 Mission Falls Court
Fremont,  CA  94539
Applicant Contact IN K. MUN
Correspondent
The Cro Group, Inc.
32 Harrison St.
Melrose,  MA  02176
Correspondent Contact GLEN EMELOCK
Regulation Number882.4560
Classification Product Code
OJP  
Subsequent Product Code
OLO  
Date Received03/23/2015
Decision Date 10/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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