Clearance Summary
HELENA SYSTEM received FDA 510(k) clearance under submission number K110177, sponsored by Royal Oak Medical Devices. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-04-21.
- Submission: K110177
- Applicant / Sponsor: Royal Oak Medical Devices
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2011-04-21
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.