The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Vanguard Asymmetrical Patellar Component.
| Device ID | K110362 |
| 510k Number | K110362 |
| Device Name: | VANGUARD ASYMMETRICAL PATELLAR COMPONENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tamara West |
| Correspondent | Tamara West BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-08 |
| Decision Date | 2011-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868494994 | K110362 | 000 |
| 00889024581890 | K110362 | 000 |
| 00889024581906 | K110362 | 000 |
| 00889024581913 | K110362 | 000 |
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| 00880304555693 | K110362 | 000 |
| 00880304555709 | K110362 | 000 |
| 00880304612563 | K110362 | 000 |
| 00880304612570 | K110362 | 000 |
| 00880304612587 | K110362 | 000 |
| 00880304849549 | K110362 | 000 |