K250304
- 510(k) number
- K250304
- Device name
- TITANEX Screw Systems
- Applicant
- Vilex, LLC TN · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2025-03-05
- Date received
- 2025-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K250304.pdf
Official FDA record: K250304
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.