Clearance Summary
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS received FDA 510(k) clearance under submission number K130073, sponsored by Mikron Makina Sanayi VE Ticaret 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 2013-12-16.
- Submission: K130073
- Applicant / Sponsor: Mikron Makina Sanayi VE Ticaret Ltd. Sti.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2013-12-16
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.