510(k) K200433
K200433 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "iBalance UKA Tibial Tray Implant". The FDA issued a decision of Substantially Equivalent on Mar 17, 2020. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Arthrex, Inc. has 352 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 17, 2020
- Date Received
- Feb 21, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3520
- Review Panel
- OR
- Submission Type
- 510(k)