Clearance Summary
PLASMAFIT ACETABULAR CUP AND VITELENE INSERT received FDA 510(k) clearance under submission number K122783, sponsored by Aesculap Implant System, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-10-30.
- Submission: K122783
- Applicant / Sponsor: Aesculap Implant System, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2013-10-30
Classification & Regulation
This clearance is catalogued under FDA product code OQG and 21 CFR 888.3358, within the Orthopedic review panel as a Class II device.