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AETOS Shoulder System

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
AETOS Shoulder System FDA UDI
Generic Name
Humeral body extension prosthesis FDA UDI
Device Name
HUMERAL SPACER +9 SMALL FDA UDI
Model / Reference
SPC-0990-204-S FDA UDI
Description
HUMERAL SPACER +9 SMALL FDA UDI

Identifiers

Catalog Number
SPC-0990-204-S FDA UDI
Primary DI / UDI-DI
00885556871683 FDA UDI
510(k) Number
K230572 FDA UDI
FDA Product Code
HSD FDA UDI
PHX FDA UDI
KWT FDA UDI
KWS FDA UDI
GMDN Term
Humeral body extension prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3690 FDA UDI
888.3660 FDA UDI
888.3650 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

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

Category: Humeral body extension prosthesis

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

Similar devices

Also classified as Humeral body extension prosthesis.

Cleared under the same submission

K230572 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 056e587d-dade-4b4f-b312-30bd1cb76037 36 fields · synced Jun 8, 2026