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Patella Sizer/Clamp/Drill Guide, Klassic ONE, Tip

FDA UDI

Class I (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name
Patella Sizer/Clamp/Drill Guide, Klassic ONE, Tip FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name
Patella Sizer/Clamp/Drill Guide, Tip FDA UDI
Model / Reference
2311.00.000 FDA UDI
Description
Patella Sizer/Clamp/Drill Guide, Tip FDA UDI

Identifiers

Primary DI / UDI-DI
00819251027762 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

Patella Sizer/Clamp/Drill Guide, Klassic ONE, Tip 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 474faac2-6e13-4c60-908e-5f1aaecc83ee 35 fields · synced Jun 8, 2026