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Global Advantage

FDA UDI

Class II (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name
GLOBAL ADVANTAGE FDA UDI
Generic Name
Press-fit shoulder humeral stem prosthesis FDA UDI
Device Name
GLOBAL ADVANTAGE REVISION STEM SIZE 10 210mm FDA UDI
Model / Reference
1137-10-010 FDA UDI
Description
GLOBAL ADVANTAGE REVISION STEM SIZE 10 210mm FDA UDI

Identifiers

Catalog Number
113710010 FDA UDI
Primary DI / UDI-DI
10603295007128 FDA UDI
510(k) Number
K992065 FDA UDI
FDA Product Code
KWS FDA UDI
HSD FDA UDI
GMDN Term
Press-fit shoulder humeral stem 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

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: Press-fit shoulder humeral stem prosthesis

Global Advantage by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Press-fit shoulder humeral stem prosthesis.

Cleared under the same submission

K992065 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy Orthopaedics, Inc.

Sources (1)

  • FDA UDI 555cc475-628c-4683-ac73-229832e59788 36 fields · synced Jun 8, 2026