510(k) K170534
K170534 is an FDA 510(k) premarket notification submitted by Otis Biotech Co., Ltd. for the device "PROLIXUS TOTAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on Nov 9, 2017. 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. Otis Biotech Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 9, 2017
- Date Received
- Feb 23, 2017
- 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)