Clearance Summary
METS MODULAR TOTAL FEMUR received FDA 510(k) clearance under submission number K121055, sponsored by Stanmore Implants Worldwide , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2012-09-19.
- Submission: K121055
- Applicant / Sponsor: Stanmore Implants Worldwide , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3350
- Decision date: 2012-09-19
Classification & Regulation
This clearance is catalogued under FDA product code JDI and 21 CFR 888.3350, within the Orthopedic review panel as a Class II device.