Clearance Summary
OLECRA INTRAMEDULLARY FIXATION SYSTEM received FDA 510(k) clearance under submission number K110322, sponsored by Mylad Orthopedic Solutions. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-03-04.
- Submission: K110322
- Applicant / Sponsor: Mylad Orthopedic Solutions
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2011-03-04
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.