Fusion Rod 90mm 83198
Fusion Rod 90mm 83198 is a Class II device made by Premia Spine Ltd, cleared under FDA 510(k) K182598 on 13 Nov 2018 and listed in FDA GUDID since 18 Oct 2026 (UDI-DI 07290014080140), active as of 2 Nov 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 | Number07290014080140 | Date18 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182598 | Date13 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 07290014080140
- FDA 510(k) database K182598
Across registries
- FDA 510(k) K182598 decided 13 Nov 2018 Active
- FDA GUDID UDI-DI 07290014080140 listed 18 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K182598
- Listed FDA GUDID 07290014080140
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fusion Rod 90mm
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / reference
- 83198
- Primary DI / UDI-DI
- 07290014080140
- 510(k) Number
- FDA product code
- NKB
- 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
- Moist Heat or Steam Sterilization
- Size
- Length — 90 Millimeter