510(k) K242412
K242412 is an FDA 510(k) premarket notification submitted by Medisurge, LLC for the device "Agility Symmetric Total Knee System". The FDA issued a decision of Substantially Equivalent on November 6, 2024. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2024
- Date Received
- August 14, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3565
- Review Panel
- OR
- Submission Type