Threshold Articulating Perc Rod 10-10-08-8
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM7405306090 | Date9 Jan 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143403 | Date18 Dec 2014 | StatusActive |
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- Withdrawn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
- Threshold Articulating Perc Rod
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / Ref / Catalog
- 10-10-08-8, 530-6090
- Primary DI / UDI-DI
- M7405306090
- 510(k) Number
- FDA product code
- NKB, MNI, MNH
- GMDN term
- Bone-screw internal spinal fixation system rod
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
- MRI safety
- MR Unsafe
- Size
- Length — 90 Millimeter
Other devices from Spineology Inc.
Properties
Other properties (8)
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Manufacturing date: No