The following data is part of a premarket notification filed by Zimmer Inc. with the FDA for Vanguard Xp Knee System.
| Device ID | K190068 |
| 510k Number | K190068 |
| Device Name: | Vanguard XP Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Zimmer Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Contact | Charles Neitzel |
| Correspondent | Charles Neitzel Zimmer Inc. P.O. Box 708 Warsaw, IN 46581 -0708 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | MBV |
| Subsequent Product Code | OIY |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-15 |
| Decision Date | 2019-06-04 |