Clearance Summary
MAK OSS FEMORAL KNEE COMPONENTS received FDA 510(k) clearance under submission number K131393, sponsored by Biomet Orthopedics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-10-24.
- Submission: K131393
- Applicant / Sponsor: Biomet Orthopedics Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3510
- Decision date: 2013-10-24
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.