Clearance Summary
AMT POLYAXIAL PEDICLE SCREW received FDA 510(k) clearance under submission number K022768, sponsored by Micron Precision Engineering, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2002-11-13.
- Submission: K022768
- Applicant / Sponsor: Micron Precision Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2002-11-13
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.