The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Columbus Total Knee System As Columbus Revision Knee System Enduro Knee System.
| Device ID | K120955 |
| 510k Number | K120955 |
| Device Name: | COLUMBUS TOTAL KNEE SYSTEM AS 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 | Kathy A Racosky |
| Correspondent | Kathy A Racosky AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-30 |
| Decision Date | 2012-12-17 |
| Summary: | summary |