CoreLink LATERAL SCREW 90755-50
by Corelink LLC
CoreLink LATERAL SCREW 90755-50 is a Class II device made by Corelink LLC, cleared under FDA 510(k) K190016 on 12 Jun 2019 and listed in FDA GUDID since 3 Jan 2025 (UDI-DI M7259075550), 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 | NumberM7259075550 | Date3 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190016 | Date12 Jun 2019 | StatusActive |
Official records
- FDA 510(k) database K190016
Across registries
- FDA 510(k) K190016 decided 12 Jun 2019 Active
- FDA GUDID UDI-DI M7259075550 listed 3 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K190016
- Listed FDA GUDID M7259075550
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CoreLink LATERAL SCREW
- Generic name
- Orthopaedic bone screw (non-sliding)
- Model / reference
- 90755-50
- Primary DI / UDI-DI
- M7259075550
- 510(k) Number
- FDA product code
- KWQ
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization