← Back to catalogue

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 STANDARD STEM SIZE 6 108mm FDA UDI
Model / Reference
1137-06-000 FDA UDI
Description
GLOBAL ADVANTAGE STANDARD STEM SIZE 6 108mm FDA UDI

Identifiers

Catalog Number
113706000 FDA UDI
Primary DI / UDI-DI
10603295007067 FDA UDI
510(k) Number
K992065 FDA UDI
FDA Product Code
HSD FDA UDI
KWS FDA UDI
GMDN Term
Press-fit shoulder humeral stem prosthesis FDA UDI

Classification

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Depuy Orthopaedics, Inc.

Sources (1)

  • FDA UDI d7d6c640-8a2a-4a7f-bcf0-dcc6cf503e21 36 fields · synced Jun 8, 2026