The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Vanguard Xp Knee System.
| Device ID | K153657 |
| 510k Number | K153657 |
| Device Name: | Vanguard XP Knee System |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Contact | Julie Gantenberg |
| Correspondent | Julie Gantenberg BIOMET, INC. 56 EAST BELL DRIVE Warsaw, IN 46581 |
| Product Code | MBH |
| Subsequent Product Code | JWH |
| Subsequent Product Code | MBV |
| Subsequent Product Code | OIY |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304208001 | K153657 | 000 |
| 00880304207981 | K153657 | 000 |
| 00880304207974 | K153657 | 000 |
| 00880304207967 | K153657 | 000 |