Clearance Summary
TALON DISTALFIX PROXIMAL FEMORAL NAIL received FDA 510(k) clearance under submission number K111352, sponsored by Orthopedic Designs North America, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-08-22.
- Submission: K111352
- Applicant / Sponsor: Orthopedic Designs North America, Inc.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2011-08-22
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.