LineSider LS-RD55B110
LineSider LS-RD55B110 is a Class II device made by Integrity Implants Inc., cleared under FDA 510(k) K190360 on 21 Jun 2019 and listed in FDA GUDID since 7 Oct 2019 (UDI-DI 00810004720398), 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 | Number00810004720398 | Date7 Oct 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190360 | Date21 Jun 2019 | StatusActive |
Official records
- AccessGUDID record 00810004720398
- FDA 510(k) database K190360
Across registries
- FDA 510(k) K190360 decided 21 Jun 2019 Active
- FDA GUDID UDI-DI 00810004720398 listed 7 Oct 2019 Listed
Timeline
- Cleared FDA 510(k) K190360
- Listed FDA GUDID 00810004720398
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LineSider
- Generic name
- Bone-screw internal spinal fixation system rod
- Model / Ref / Catalog
- LS-RD55B110
- Description
- Ti Rod - 5.5mm 110mm Curved
- Primary DI / UDI-DI
- 00810004720398
- 510(k) Number
- FDA product code
- NKB, 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
Similar devices in this category
Other devices filed under Bone-screw internal spinal fixation system rod.