Arsenal 47001-55-045
Arsenal 47001-55-045 is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K161363 on 10 Jun 2016 and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 00844856072664), 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 | FDA 510(k)SESE | NumberK161363 | Date10 Jun 2016 | StatusActive |
| United States | GUDID listing | Number00844856072664 | Date24 Sep 2014 | StatusListed |
Official records
- AccessGUDID record 00844856072664
- FDA 510(k) database K161363
Across registries
- FDA 510(k) K161363 decided 10 Jun 2016 Active
- FDA GUDID UDI-DI 00844856072664 listed 24 Sep 2014 Listed
Timeline
- Listed FDA GUDID 00844856072664
- Cleared FDA 510(k) K161363
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arsenal
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / reference
- 47001-55-045
- Primary DI / UDI-DI
- 00844856072664
- 510(k) Number
- FDA product code
- MNH, OSH, NKB, MNI, KWP
- GMDN term
- Bone-screw internal spinal fixation system rod
- Device class
- Class II
- Regulation number
- 888.3070, 888.3050
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Length — 45 MillimeterOuter Diameter — 5.5 Millimeter