K231504
- 510(k) number
- K231504
- Device name
- TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System
- Applicant
- Vilex, LLC TN · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2023-09-11
- Date received
- 2023-05-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K231504.pdf
Official FDA record: K231504
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.