Clearance Summary
INTRAMEDULLARY NAIL AND SCREWS-NEONAIL received FDA 510(k) clearance under submission number K141103, sponsored by Neoortho Produtos Ortopedicos S/A. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2014-09-23.
- Submission: K141103
- Applicant / Sponsor: Neoortho Produtos Ortopedicos S/A
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2014-09-23
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.