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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 stem prosthesis FDA UDI
Device Name
PROFIX NEUTRAL STEM 14MM X 150MM SLOTTED FDA UDI
Model / Reference
71501214 FDA UDI
Description
PROFIX NEUTRAL STEM 14MM X 150MM SLOTTED FDA UDI

Identifiers

Catalog Number
71501214 FDA UDI
Primary DI / UDI-DI
03596010218520 FDA UDI
510(k) Number
K933958 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Knee femur stem prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K933958 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 48720250-d846-41a3-a23e-12c40492d08a 37 fields · synced Jun 8, 2026