Clearance Summary
Mikron Spinal Fixation System received FDA 510(k) clearance under submission number K171497, sponsored by Mikron Makina Sanayi Ticaret Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-10-12.
- Submission: K171497
- Applicant / Sponsor: Mikron Makina Sanayi Ticaret Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2017-10-12
Classification & Regulation
This clearance is catalogued under FDA product code MNI and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.