SafeOp 3 880-3006
SafeOp 3 880-3006 is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K234092 on 19 Apr 2024 and listed in FDA GUDID since 1 Oct 2024 (UDI-DI 00190376542942), 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 | Number00190376542942 | Date1 Oct 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK234092 | Date19 Apr 2024 | StatusActive |
Official records
- AccessGUDID record 00190376542942
- FDA 510(k) database K234092
Across registries
- FDA 510(k) K234092 decided 19 Apr 2024 Active
- FDA GUDID UDI-DI 00190376542942 listed 1 Oct 2024 Listed
Timeline
- Cleared FDA 510(k) K234092
- Listed FDA GUDID 00190376542942
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SafeOp 3
- Generic name
- Analytical non-scalp cutaneous electrode
- Model / reference
- 880-3006
- Primary DI / UDI-DI
- 00190376542942
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Analytical non-scalp cutaneous electrode
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Analytical non-scalp cutaneous electrode.