The following data is part of a premarket notification filed by Aesculap Implant System, Inc. with the FDA for Vega Knee System.
| Device ID | K101281 |
| 510k Number | K101281 |
| Device Name: | VEGA KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Kathy A Racosky |
| Correspondent | Kathy A Racosky AESCULAP IMPLANT SYSTEM, INC. 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 | 2010-05-06 |
| Decision Date | 2010-07-30 |