The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Vanguard Removable Molded Poly Tibia.
| Device ID | K102580 |
| 510k Number | K102580 |
| Device Name: | VANGUARD REMOVABLE MOLDED POLY TIBIA |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46580 |
| Contact | Tamara J West |
| Correspondent | Tamara J West BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46580 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-08 |
| Decision Date | 2011-03-03 |
| Summary: | summary |