Arcus 16122-01
Arcus 16122-01 is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K191723 on 18 Oct 2019 and listed in FDA GUDID since 1 Dec 2019 (UDI-DI 00190376215877), 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 | Number00190376215877 | Date1 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191723 | Date18 Oct 2019 | StatusActive |
Official records
- AccessGUDID record 00190376215877
- FDA 510(k) database K191723
Across registries
- FDA 510(k) K191723 decided 18 Oct 2019 Active
- FDA GUDID UDI-DI 00190376215877 listed 1 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K191723
- Listed FDA GUDID 00190376215877
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arcus
- Generic name
- Neurophysiologic monitoring system
- Model / reference
- 16122-01
- Primary DI / UDI-DI
- 00190376215877
- 510(k) Number
- FDA product code
- PDQ, ETN
- GMDN term
- Neurophysiologic monitoring system
- Device class
- Class II
- Regulation number
- 874.1820
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Neurophysiologic monitoring system.