Clearance Summary
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, received FDA 510(k) clearance under submission number K123907, sponsored by Biomet Manufacturing 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 2013-09-03.
- Submission: K123907
- Applicant / Sponsor: Biomet Manufacturing Corp
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3540
- Decision date: 2013-09-03
Classification & Regulation
This clearance is catalogued under FDA product code KRR and 21 CFR 888.3540, within the Orthopedic review panel as a Class II device.