510(k) K191211
K191211 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "JOURNEY II Unicompartmental Knee System". The FDA issued a decision of Substantially Equivalent on Jul 25, 2019. 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. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 25, 2019
- Date Received
- May 6, 2019
- Clearance Type
- Traditional
- 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)