The following data is part of a premarket notification filed by Aesculap Implants Systems, Llc with the FDA for Vega Knee System, Columbus Total Knee System.
| Device ID | K143443 |
| 510k Number | K143443 |
| Device Name: | VEGA Knee System, Columbus Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Aesculap Implants Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Julie Tom Wing |
| Correspondent | Lisa Boyle Aesculap Implants 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 | 2014-12-02 |
| Decision Date | 2015-03-25 |
| Summary: | summary |