SafeOp 3 AIX1321-S
SafeOp 3 AIX1321-S 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 12 Jul 2024 (UDI-DI 00190376549392), 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 | Number00190376549392 | Date12 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK234092 | Date19 Apr 2024 | StatusActive |
Official records
- AccessGUDID record 00190376549392
- FDA 510(k) database K234092
Across registries
- FDA 510(k) K234092 decided 19 Apr 2024 Active
- FDA GUDID UDI-DI 00190376549392 listed 12 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K234092
- Listed FDA GUDID 00190376549392
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SafeOp 3
- Generic name
- Nerve-locating system probe, single-use
- Model / reference
- AIX1321-S
- Primary DI / UDI-DI
- 00190376549392
- 510(k) Number
- FDA product code
- ETN, PDQ
- GMDN term
- Nerve-locating system probe, single-use
- Device class
- Class II
- Regulation number
- 874.1820
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Nerve-locating system probe, single-use.