The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Vanguard Anatomic Patella Groove (apg) / Vanguard V Groove.
| Device ID | K061433 |
| 510k Number | K061433 |
| Device Name: | VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Tracy Bickel-johnson |
| Correspondent | Tracy Bickel-johnson BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-24 |
| Decision Date | 2006-08-21 |
| Summary: | summary |