Clearance Summary
Valkyrie Thoracic Fixation System received FDA 510(k) clearance under submission number K211695, sponsored by Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-06-23.
- Submission: K211695
- Applicant / Sponsor: Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2021-06-23
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.