510(k) K150544
K150544 is an FDA 510(k) premarket notification submitted by Aesculap Implant Systems, LLC for the device "Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System". The FDA issued a decision of Substantially Equivalent on May 29, 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. Aesculap Implant Systems, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2015
- Date Received
- March 3, 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