Promos

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: PROMOS FDA UDI
Generic Name: Shoulder humeral body prosthesis FDA UDI
Device Name: PLUS PROMOS INCLINATION SET 24MM FDA UDI
Model / Reference: 75042184 FDA UDI
Description: PLUS PROMOS INCLINATION SET 24MM FDA UDI

Identifiers

Catalog Number: 75042184 FDA UDI
Primary DI / UDI-DI: 07611996120547 FDA UDI
510(k) Number: K113012 FDA UDI
FDA Product Code: KWS FDA UDI
HSD FDA UDI
GMDN Term: Shoulder humeral body prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Shoulder humeral body prosthesis

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

Similar devices

Also classified as Shoulder humeral body prosthesis.

Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
Equinoxe — Exactech, Inc. · Class II
Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
Anatomical Shoulder™ Domelock® — Zimmer, Inc. · Class II
HemiCAP® — ARTHROSURFACE INCORPORATED · Class II
Humeris Shoulder — FX SOLUTIONS · Class II
OVOMotion™ — ARTHROSURFACE INCORPORATED · Class II
HemiCAPOVO® — ARTHROSURFACE INCORPORATED · Class II

Cleared under the same submission

K113012 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI c003714f-721e-494f-9d9e-ee4aa375fe97 36 fields · synced Jun 6, 2026