Clearance Summary
PATIENT SPECIFIC DISTAL FEMORAL received FDA 510(k) clearance under submission number K140898, sponsored by Stanmore Implants Worldwide , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-01-20.
- Submission: K140898
- Applicant / Sponsor: Stanmore Implants Worldwide , Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3510
- Decision date: 2015-01-20
Classification & Regulation
This clearance is catalogued under FDA product code KRO and 21 CFR 888.3510, within the Orthopedic review panel as a Class II device.