Modified Mini Tray +10 0mm Offset SSI005786
Modified Mini Tray +10 0mm Offset SSI005786 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K181611 on 24 Sep 2018 and listed in FDA GUDID since 13 Jan 2020 (UDI-DI 00889024585324), 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 | Number00889024585324 | Date13 Jan 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181611 | Date24 Sep 2018 | StatusActive |
Official records
- AccessGUDID record 00889024585324
- FDA 510(k) database K181611
Across registries
- FDA 510(k) K181611 decided 24 Sep 2018 Active
- FDA GUDID UDI-DI 00889024585324 listed 13 Jan 2020 Listed
Timeline
- Cleared FDA 510(k) K181611
- Listed FDA GUDID 00889024585324
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Modified Mini Tray +10 0mm Offset
- Generic name
- Reverse shoulder cup prosthesis trial, reusable
- Model / Ref / Catalog
- SSI005786
- Primary DI / UDI-DI
- 00889024585324
- 510(k) Number
- FDA product code
- PHX, KWT, KWS, PAO
- GMDN term
- Reverse shoulder cup prosthesis trial, reusable
- Device class
- Class II
- Regulation number
- 888.3660, 888.3650
- GUDID distribution status
- In Commercial Distribution