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TMINI™ Navigation Console

FDA UDI

Class II (US FDA UDI)

by Think Surgical Inc.

Identity

Trade Name
TMINI™ Navigation Console FDA UDI
Generic Name
Robotic surgical navigation system FDA UDI
Model / Reference
108757 FDA UDI

Identifiers

Catalog Number
108757 FDA UDI
Primary DI / UDI-DI
M9461087570 FDA UDI
510(k) Number
K230202 FDA UDI
K232802 FDA UDI
K241031 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Robotic surgical navigation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Robotic surgical navigation system

TMINI™ Navigation Console by Think Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical navigation system.

Cleared under the same submission

K230202 also covers:

K232802 also covers:

K241031 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Think Surgical Inc.

Sources (1)

  • FDA UDI 2cb37c9b-c78d-44cd-be01-1a2430fa5e5c 35 fields · synced May 30, 2026