The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Columbus Total Knee System, Columbus Revision Knee System, Enduro Knee System.
| Device ID | K150544 |
| 510k Number | K150544 |
| Device Name: | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Julie Tom Wing |
| Correspondent | Lisa M Boyle AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-03 |
| Decision Date | 2015-05-29 |