Arsenal 47005-55-070
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161363 | Date10 Jun 2016 | StatusActive |
| United States | GUDID listing | Number00844856073128 | Date24 Sep 2014 | StatusListed |
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
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- Withdrawn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
- 47005-55-070
- Primary DI / UDI-DI
- 00844856073128
- 510(k) Number
- FDA product code
- MNH, MNI, NKB, OSH, 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 — 70 MillimeterOuter Diameter — 5.5 Millimeter
Other devices from Alphatec Spine, Inc.
Properties
Other properties (10)
- Supplied sterile: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No
- Manufacturing date: No