K240484
- 510(k) number
- K240484
- Device name
- MSFX Mikron Cervical Anterior Plate System
- Applicant
- Mikron Makina Sanayi VE Ticaret Ltd. Sti. TR
- Product code
- KWQ — Appliance, Fixation, Spinal Intervertebral Body
- Decision date
- 2024-04-17
- Date received
- 2024-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K240484.pdf
Official FDA record: K240484
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.