ProMIS™ Fixation System 87511
ProMIS™ Fixation System 87511 is a Class II device made by Premia Spine Ltd, cleared under FDA 510(k) K231844 on 7 Jul 2023 and listed in FDA GUDID since 25 May 2026 (UDI-DI 07290014381254), 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 | Number07290014381254 | Date25 May 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231844 | Date7 Jul 2023 | StatusActive |
Official records
- AccessGUDID record 07290014381254
- FDA 510(k) database K231844
Across registries
- FDA 510(k) K231844 decided 7 Jul 2023 Active
- FDA GUDID UDI-DI 07290014381254 listed 25 May 2026 Listed
Timeline
- Cleared FDA 510(k) K231844
- Listed FDA GUDID 07290014381254
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ProMIS™ Fixation System
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / reference
- 87511
- Primary DI / UDI-DI
- 07290014381254
- 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 — 250 MillimeterOuter Diameter — 6 Millimeter