Alliance™ SAGL2145
Alliance™ SAGL2145 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K193180 on 24 Feb 2020 and listed in FDA GUDID since 25 Feb 2022 (UDI-DI 00889024644830), active as of 22 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 | Number00889024644830 | Date25 Feb 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193180 | Date24 Feb 2020 | StatusActive |
Official records
- AccessGUDID record 00889024644830
- FDA 510(k) database K193180
Across registries
- FDA 510(k) K193180 decided 24 Feb 2020 Active
- FDA GUDID UDI-DI 00889024644830 listed 25 Feb 2022 Listed
Timeline
- Cleared FDA 510(k) K193180
- Listed FDA GUDID 00889024644830
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Alliance™
- Generic name
- Shoulder glenoid fossa prosthesis, prefabricated
- Model / Ref / Catalog
- SAGL2145
- Primary DI / UDI-DI
- 00889024644830
- 510(k) Number
- FDA product code
- KWS, KWT
- GMDN term
- Shoulder glenoid fossa prosthesis, prefabricated
- Device class
- Class II
- Regulation number
- 888.3660, 888.3650
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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