The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Patient-specific Vanguard Femoral Componets.
| Device ID | K102125 |
| 510k Number | K102125 |
| Device Name: | PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker, Ms, Rac |
| Correspondent | Gary Baker, Ms, Rac BIOMET, INC. 56 EAST BELL DR. 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 | 2010-07-29 |
| Decision Date | 2011-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304555648 | K102125 | 000 |
| 00880304555532 | K102125 | 000 |
| 00880304555525 | K102125 | 000 |
| 00880304555518 | K102125 | 000 |
| 00880304555501 | K102125 | 000 |
| 00880304555495 | K102125 | 000 |
| 00880304555488 | K102125 | 000 |
| 00880304555471 | K102125 | 000 |
| 00880304555464 | K102125 | 000 |
| 00880304555549 | K102125 | 000 |
| 00880304555556 | K102125 | 000 |
| 00880304555631 | K102125 | 000 |
| 00880304555624 | K102125 | 000 |
| 00880304555617 | K102125 | 000 |
| 00880304555600 | K102125 | 000 |
| 00880304555594 | K102125 | 000 |
| 00880304555587 | K102125 | 000 |
| 00880304555570 | K102125 | 000 |
| 00880304555563 | K102125 | 000 |
| 00880304555457 | K102125 | 000 |