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Global Ap

FDA UDI

Class II (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name
GLOBAL AP FDA UDI
Generic Name
Press-fit shoulder humeral stem prosthesis FDA UDI
Device Name
GLOBAL AP REVISION STEM SIZE 8 197mm FDA UDI
Model / Reference
1130-08-010 FDA UDI
Description
GLOBAL AP REVISION STEM SIZE 8 197mm FDA UDI

Identifiers

Catalog Number
113008010 FDA UDI
Primary DI / UDI-DI
10603295005476 FDA UDI
510(k) Number
K060874 FDA UDI
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
Not 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

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

Cleared under the same submission

K060874 also covers:

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 65975ecb-cf03-4162-a7f3-200e5658e936 37 fields · synced Jun 8, 2026