Identity
- Trade Name
- GLOBAL ADVANTAGE FDA UDI
- Generic Name
- Stem-fixed metallic humeral head prosthesis FDA UDI
- Device Name
- GLOBAL ADVANTAGE ECCENTRIC HEAD SIZE 56mm x 18mm FDA UDI
- Model / Reference
- 1128-56-110 FDA UDI
- Description
- GLOBAL ADVANTAGE ECCENTRIC HEAD SIZE 56mm x 18mm FDA UDI
Identifiers
- Catalog Number
- 112856110 FDA UDI
- Primary DI / UDI-DI
- 10603295005278 FDA UDI
- 510(k) Number
- K992065 FDA UDI
- FDA Product Code
- KWS FDA UDIHSD FDA UDI
- GMDN Term
- Stem-fixed metallic humeral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 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: Stem-fixed metallic humeral head prosthesis
Global Advantage by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K992065 also covers:
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 7d0957b2-4b68-4ba2-ad1d-ecb7541e8c6e 36 fields · synced Jun 8, 2026