The following data is part of a premarket notification filed by Aesculap Implant Systems with the FDA for Vega Knee System.
Device ID | K140452 |
510k Number | K140452 |
Device Name: | VEGA KNEE SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. Center Valley, PA 18034 |
Contact | Julie Tom Wing |
Correspondent | Julie Tom Wing AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. 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 | 2014-02-24 |
Decision Date | 2014-03-25 |
Summary: | summary |