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Emperion

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
EMPERION FDA UDI
Generic Name
Coated hip femur prosthesis, modular FDA UDI
Device Name
EMPERION 17 SLEEVE LARGE CONE 1 SPOUT FDA UDI
Model / Reference
71291687 FDA UDI
Description
EMPERION 17 SLEEVE LARGE CONE 1 SPOUT FDA UDI

Identifiers

Catalog Number
71291687 FDA UDI
Primary DI / UDI-DI
03596010561909 FDA UDI
510(k) Number
K042127 FDA UDI
FDA Product Code
MEH FDA UDI
GMDN Term
Coated hip femur prosthesis, modular FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 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

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

Cleared under the same submission

K042127 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 baaaee83-7fb9-434c-b3e7-fe4bc9793d7a 37 fields · synced Jun 8, 2026