510(k) K153437
K153437 is an FDA 510(k) premarket notification submitted by Omnilife Science for the device "Apex Revision Knee System". The FDA issued a decision of Substantially Equivalent on December 21, 2015. 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. Omnilife Science has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2015
- Date Received
- November 27, 2015
- Clearance Type
- Special
- 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