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Femur Tracking Array

FDA UDI

Class II (US FDA UDI)

by Think Surgical Inc.

Identity

Trade Name
Femur Tracking Array FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Model / Reference
109003 FDA UDI

Identifiers

Catalog Number
109003 FDA UDI
Primary DI / UDI-DI
M9461090030 FDA UDI
510(k) Number
K230202 FDA UDI
K232802 FDA UDI
K241031 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Femur Tracking Array by Think Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.

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 d518f13d-c13d-486e-8cf2-c110811194e6 35 fields · synced May 30, 2026