Clearance Summary
PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT received FDA 510(k) clearance under submission number K140900, sponsored by Stanmore Worldwide Implants , 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 2015-02-12.
- Submission: K140900
- Applicant / Sponsor: Stanmore Worldwide Implants , Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3510
- Decision date: 2015-02-12
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.