Global Advantage 1137-08-000
Global Advantage 1137-08-000 (113708000) 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 10603295007081), 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 | Number10603295007081 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK992065 | Date12 Jul 1999 | StatusActive |
Official records
- AccessGUDID record 10603295007081
- FDA 510(k) database K992065
Across registries
- FDA 510(k) K992065 decided 12 Jul 1999 Active
- FDA GUDID UDI-DI 10603295007081 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K992065
- Listed FDA GUDID 10603295007081
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Global Advantage
- Generic name
- Press-fit shoulder humeral stem prosthesis
- Model / Ref / Catalog
- 1137-08-000, 113708000
- Primary DI / UDI-DI
- 10603295007081
- 510(k) Number
- FDA product code
- HSD, KWS
- GMDN term
- Press-fit shoulder humeral stem prosthesis
- Device class
- Class II
- Regulation number
- 888.3690, 888.3660
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Press-fit shoulder humeral stem prosthesis.