Clearance Summary
GMK Revision Femoral Distal Augmentation received FDA 510(k) clearance under submission number K163311, sponsored by Medacta International S.A.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-12-21.
- Submission: K163311
- Applicant / Sponsor: Medacta International S.A.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3510
- Decision date: 2016-12-21
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.