FDA.reportPublic FDA data

510(k) K232802

Device
TMINI? Miniature Robotic System
Applicant
THINK Surgical, Inc.
510(k) number
K232802
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-12
Date received
2023-09-12
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anand Patel
Address
47201 Lakeview Blvd. Fremont CA US 94538 94538

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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