510(k) K200122
K200122 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "MOTO PFJ System". The FDA issued a decision of Substantially Equivalent on April 20, 2020. The device falls under product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3540. Medacta International S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2020
- Date Received
- January 21, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3540
- Review Panel
- OR
- Submission Type