Clearance Summary
MSFX MIKRON PEEK CAGES received FDA 510(k) clearance under submission number K252781, sponsored by Mikron Makina Sanayi VE Tic. Ltd. Sti.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-12-19.
- Submission: K252781
- Applicant / Sponsor: Mikron Makina Sanayi VE Tic. Ltd. Sti.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2025-12-19
Classification & Regulation
This clearance is catalogued under FDA product code ODP and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.