Clearance Summary
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) received FDA 510(k) clearance under submission number K122541, sponsored by Orthofix Srl. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2012-09-20.
- Submission: K122541
- Applicant / Sponsor: Orthofix Srl
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2012-09-20
Classification & Regulation
This clearance is catalogued under FDA product code KTW and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.