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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 K242264
Device Name TMINI Miniature Robotic System
Applicant
THINK Surgical, Inc.
47201 Lakeview Blvd.
Fremont,  CA  94528
Applicant Contact Anand Patel
Correspondent
THINK Surgical, Inc.
47201 Lakeview Blvd.
Fremont,  CA  94528
Correspondent Contact Anand Patel
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/01/2024
Decision Date 08/23/2024
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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