510(k) K180317
K180317 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System". The FDA issued a decision of Substantially Equivalent on May 4, 2018. 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. Microport Orthopedics, Inc. has 38 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2018
- Date Received
- Feb 5, 2018
- 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
- 510(k)