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Tibial Sizer and Trial, Klassic ONE

FDA UDI

Class I (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name
Tibial Sizer and Trial, Klassic ONE FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name
Tibial Sizer and Trial, Sz 5 FDA UDI
Model / Reference
2234.05.000 FDA UDI
Description
Tibial Sizer and Trial, Sz 5 FDA UDI

Identifiers

Primary DI / UDI-DI
00819251027526 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

No

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

Tibial Sizer and Trial, Klassic ONE by Total Joint Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Total Joint Orthopedics, Inc.

Sources (1)

  • FDA UDI 2db0fbfb-e881-4b10-b7d7-1b1952b8dabc 36 fields · synced May 31, 2026