Fixation screw A40047
Fixation screw A40047 is a Class II device made by Ecential Robotics, cleared under FDA 510(k) K231886 on 27 Jul 2023 (1 earlier submission) and listed in FDA GUDID since 4 Sep 2023 (UDI-DI 03701311500742), 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 | Number03701311500742 | Date4 Sep 2023 | StatusListed |
| United States | FDA 510(k) | NumberK231886 | Date27 Jul 2023 | StatusActive |
Official records
- AccessGUDID record 03701311500742
- FDA 510(k) database K231886
- FDA 510(k) database K221028
Across registries
- FDA 510(k) K231886 decided 27 Jul 2023 Active
- FDA GUDID UDI-DI 03701311500742 listed 4 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K221028
- Cleared FDA 510(k) K231886
- Listed FDA GUDID 03701311500742
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fixation screw
- Generic name
- Optical surgical tracking system spatial marker connector
- Model / reference
- A40047
- Primary DI / UDI-DI
- 03701311500742
- FDA product code
- OLO
- GMDN term
- Optical surgical tracking system spatial marker connector
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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