Clearance Summary
Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill received FDA 510(k) clearance under submission number K200151, sponsored by Zimmer, 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 2020-03-17.
- Submission: K200151
- Applicant / Sponsor: Zimmer, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3520
- Decision date: 2020-03-17
Classification & Regulation
This clearance is catalogued under FDA product code HSX and 21 CFR 888.3520, within the Orthopedic review panel as a Class II device.