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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 K250877
Device Name TMINI Miniature Robotic System
Applicant
THINK Surgical, Inc.
47201 Lakeview Blvd.
Fremont,  CA  94538
Applicant Contact Denise Duchene
Correspondent
THINK Surgical, Inc.
47201 Lakeview Blvd.
Fremont,  CA  94538
Correspondent Contact Denise Duchene
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/24/2025
Decision Date 06/20/2025
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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