Clearance Summary
GMK Sphere CR Tibial Inserts received FDA 510(k) clearance under submission number K181635, sponsored by Medacta International S.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-08-23.
- Submission: K181635
- Applicant / Sponsor: Medacta International S.A.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2018-08-23
Classification & Regulation
This clearance is catalogued under FDA product code JWH and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.