510(k) K260010

TMINI® Miniature Robotic System by THINK Surgical, Inc. — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 3, 2026
Date Received: January 2, 2026
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Orthopedic Stereotaxic Instrument
Device Class: Class II
Regulation Number: 882.4560
Review Panel: OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Other clearances by THINK Surgical, Inc.

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K243285 — TMINI Miniature Robotic System (November 15, 2024)
K242264 — TMINI Miniature Robotic System (August 23, 2024)
K241031 — TMINI Miniature Robotic System (TMINI 1.1) (July 12, 2024)
K232802 — TMINI Miniature Robotic System (October 12, 2023)
K230202 — TMINI Miniature Robotic System (April 25, 2023)
K203468 — TCAT TKA Instrument Tray (December 20, 2021)

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