The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Vanguard Ps Open Box Porous Femoral Components.
| Device ID | K060303 |
| 510k Number | K060303 |
| Device Name: | VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 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 | 2006-02-06 |
| Decision Date | 2006-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304453753 | K060303 | 000 |
| 00880304442153 | K060303 | 000 |
| 00880304441934 | K060303 | 000 |
| 00880304441927 | K060303 | 000 |
| 00880304441729 | K060303 | 000 |
| 00880304441712 | K060303 | 000 |
| 00880304441705 | K060303 | 000 |
| 00880304441699 | K060303 | 000 |
| 00880304441682 | K060303 | 000 |
| 00880304442269 | K060303 | 000 |
| 00880304442276 | K060303 | 000 |
| 00880304453746 | K060303 | 000 |
| 00880304445451 | K060303 | 000 |
| 00880304445444 | K060303 | 000 |
| 00880304445109 | K060303 | 000 |
| 00880304445093 | K060303 | 000 |
| 00880304442306 | K060303 | 000 |
| 00880304442290 | K060303 | 000 |
| 00880304442283 | K060303 | 000 |
| 00880304441675 | K060303 | 000 |