Clearance Summary
MLP Special Locking Bone Plate System received FDA 510(k) clearance under submission number K181843, sponsored by Maxxion Medical, LLC / Baumer SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-03-04.
- Submission: K181843
- Applicant / Sponsor: Maxxion Medical, LLC / Baumer SA
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2019-03-04
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.