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Profix

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
PROFIX FDA UDI
Generic Name
Knee femur prosthesis trial, reusable FDA UDI
Device Name
PROFIX FEMORAL TRIAL RIGHT SIZE 1 FDA UDI
Model / Reference
71512110 FDA UDI
Description
PROFIX FEMORAL TRIAL RIGHT SIZE 1 FDA UDI

Identifiers

Catalog Number
71512110 FDA UDI
Primary DI / UDI-DI
03596010223357 FDA UDI
510(k) Number
K121393 FDA UDI
FDA Product Code
HRY FDA UDI
GMDN Term
Knee femur prosthesis trial, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3530 FDA UDI
Commercial Distribution
Not 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

Yes

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

Profix by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K121393 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 4d3d708e-2eab-4f56-bc4e-d2906a65e059 37 fields · synced Jun 8, 2026