LineSider LS-SC7G7555
LineSider LS-SC7G7555 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 00818613024500), 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 | Number00818613024500 | Date7 Oct 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190360 | Date21 Jun 2019 | StatusActive |
Official records
- AccessGUDID record 00818613024500
- FDA 510(k) database K190360
Across registries
- FDA 510(k) K190360 decided 21 Jun 2019 Active
- FDA GUDID UDI-DI 00818613024500 listed 7 Oct 2019 Listed
Timeline
- Cleared FDA 510(k) K190360
- Listed FDA GUDID 00818613024500
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LineSider
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / Ref / Catalog
- LS-SC7G7555
- Description
- Dual Lead Shank - Cannulated - 7.1mm Ball 7.5mm x 55mm
- Primary DI / UDI-DI
- 00818613024500
- 510(k) Number
- FDA product code
- NKB, KWP
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3070, 888.3050
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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