Trauma - Shoulders E0018145-8
Trauma - Shoulders E0018145-8 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K220847 on 3 Jan 2023 and listed in FDA GUDID since 20 Sep 2023 (UDI-DI 00885556912737), 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 | Number00885556912737 | Date20 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220847 | Date3 Jan 2023 | StatusActive |
Official records
- AccessGUDID record 00885556912737
- FDA 510(k) database K220847
Across registries
- FDA 510(k) K220847 decided 3 Jan 2023 Active
- FDA GUDID UDI-DI 00885556912737 listed 20 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K220847
- Listed FDA GUDID 00885556912737
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trauma - Shoulders
- Generic name
- Orthopaedic inorganic implant inserter/extractor, reusable
- Model / Ref / Catalog
- E0018145-8
- Primary DI / UDI-DI
- 00885556912737
- 510(k) Number
- FDA product code
- KWS
- GMDN term
- Orthopaedic inorganic implant inserter/extractor, reusable
- Device class
- Class II
- Regulation number
- 888.3660
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Orthopaedic inorganic implant inserter/extractor, reusable.