Acumed 30-0589
by Acumed LLC
Acumed 30-0589 is a Class II device made by Acumed LLC, cleared under FDA 510(k) K141383 on 13 Jun 2014 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378019777), 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 | Number10806378019777 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141383 | Date13 Jun 2014 | StatusActive |
Official records
- AccessGUDID record 10806378019777
- FDA 510(k) database K141383
Across registries
- FDA 510(k) K141383 decided 13 Jun 2014 Active
- FDA GUDID UDI-DI 10806378019777 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K141383
- Listed FDA GUDID 10806378019777
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acumed
- Generic name
- Orthopaedic bone screw (non-sliding)
- Model / reference
- 30-0589
- Primary DI / UDI-DI
- 10806378019777
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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