K253661

TMINI Miniature Robotic System

510(k) number
K253661
Device name
TMINI Miniature Robotic System
Applicant
THINK Surgical, Inc. CA · US
Product code
OLO — Orthopedic Stereotaxic Instrument
Decision date
2025-12-22
Date received
2025-11-20
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Neurology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain

Also available from FDA: K253661.pdf

Official FDA record: K253661
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.