Global Advantage 1128-48-110
Global Advantage 1128-48-110 (112848110) is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K992065 on 12 Jul 1999 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295005179), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10603295005179 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK992065 | Date12 Jul 1999 | StatusActive |
Official records
- AccessGUDID record 10603295005179
- FDA 510(k) database K992065
Across registries
- FDA 510(k) K992065 decided 12 Jul 1999 Active
- FDA GUDID UDI-DI 10603295005179 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K992065
- Listed FDA GUDID 10603295005179
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Global Advantage
- Generic name
- Stem-fixed metallic humeral head prosthesis
- Model / Ref / Catalog
- 1128-48-110, 112848110
- Primary DI / UDI-DI
- 10603295005179
- 510(k) Number
- FDA product code
- HSD, KWS
- GMDN term
- Stem-fixed metallic humeral head prosthesis
- Device class
- Class II
- Regulation number
- 888.3690, 888.3660
- GUDID distribution status
- In Commercial Distribution
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