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Global

FDA UDI

Class II (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name
GLOBAL FDA UDI
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Device Name
GLOBAL ANCHOR PEG GLENOID SIZE 56mmXL CEMENTED FDA UDI
Model / Reference
1136-45-025 FDA UDI
Description
GLOBAL ANCHOR PEG GLENOID SIZE 56mmXL CEMENTED FDA UDI

Identifiers

Catalog Number
113645025 FDA UDI
Primary DI / UDI-DI
10603295007043 FDA UDI
510(k) Number
K905786 FDA UDI
K981487 FDA UDI
FDA Product Code
KWS FDA UDI
KWT FDA UDI
GMDN Term
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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: Shoulder glenoid fossa prosthesis, prefabricated

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

Similar devices

Also classified as Shoulder glenoid fossa prosthesis, prefabricated.

Cleared under the same submission

K905786 also covers:

K981487 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 43f407f5-b003-48a1-8ae0-0ee421a5c7f6 36 fields · synced Jun 8, 2026