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TPLAN® Planning Station

FDA UDI

Class II (US FDA UDI)

by Think Surgical Inc.

Identity

Trade Name
TPLAN® Planning Station FDA UDI
Generic Name
Stereotactic system application software FDA UDI
Model / Reference
109000 FDA UDI

Identifiers

Catalog Number
109000 FDA UDI
Primary DI / UDI-DI
M9461090000 FDA UDI
510(k) Number
K230202 FDA UDI
K232802 FDA UDI
K241031 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Stereotactic system application software 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: Stereotactic system application software

TPLAN® Planning Station by Think Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stereotactic system application software.

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 1ec6faaf-4511-4d3d-8498-abc215b79ba5 35 fields · synced May 30, 2026