The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Vanguard 360 Revision Knee System.
| Device ID | K143192 |
| 510k Number | K143192 |
| Device Name: | Vanguard 360 Revision Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Contact | Jason Heckaman |
| Correspondent | Jason Heckaman Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-06 |
| Decision Date | 2015-02-12 |
| Summary: | summary |