Clearance Summary
RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS received FDA 510(k) clearance under submission number K061955, sponsored by Creative Medical Designs, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-08-04.
- Submission: K061955
- Applicant / Sponsor: Creative Medical Designs, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2006-08-04
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.