510(k) K200227
K200227 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "Journey II XR Knee Instrument". The FDA issued a decision of Substantially Equivalent on Jun 4, 2020. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 4, 2020
- Date Received
- Jan 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3560
- Review Panel
- OR
- Submission Type
- 510(k)