P.l.u.s.® U1 - R628H
P.l.u.s.® U1 - R628H is a Class II device made by Spine Vision, Inc., cleared under FDA 510(k) K013312 on 13 Feb 2002 and listed in FDA GUDID since 21 Oct 2015 (UDI-DI 03663136020389), active as of 22 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 | Number03663136020389 | Date21 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013312 | Date13 Feb 2002 | StatusActive |
Official records
- AccessGUDID record 03663136020389
- FDA 510(k) database K013312
Across registries
- FDA 510(k) K013312 decided 13 Feb 2002 Active
- FDA GUDID UDI-DI 03663136020389 listed 21 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K013312
- Listed FDA GUDID 03663136020389
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- P.l.u.s.®
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / reference
- U1 - R628H
- Primary DI / UDI-DI
- 03663136020389
- 510(k) Number
- FDA product code
- KWP, MNH, MNI
- GMDN term
- Bone-screw internal spinal fixation system rod
- Device class
- Class II
- Regulation number
- 888.3050, 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Bone-screw internal spinal fixation system rod.