The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Expandable Knee.
| Device ID | K020381 |
| 510k Number | K020381 |
| Device Name: | EXPANDABLE KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-05 |
| Decision Date | 2002-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304037120 | K020381 | 000 |
| 00880304035270 | K020381 | 000 |
| 00880304035263 | K020381 | 000 |
| 00880304035256 | K020381 | 000 |
| 00880304035249 | K020381 | 000 |
| 00880304035232 | K020381 | 000 |
| 00880304035225 | K020381 | 000 |
| 00880304035218 | K020381 | 000 |
| 00880304035201 | K020381 | 000 |
| 00880304035195 | K020381 | 000 |
| 00880304035188 | K020381 | 000 |
| 00880304035171 | K020381 | 000 |
| 00880304035140 | K020381 | 000 |
| 00880304035287 | K020381 | 000 |
| 00880304035294 | K020381 | 000 |
| 00880304037113 | K020381 | 000 |
| 00880304037106 | K020381 | 000 |
| 00880304037090 | K020381 | 000 |
| 00880304035386 | K020381 | 000 |
| 00880304035379 | K020381 | 000 |
| 00880304035362 | K020381 | 000 |
| 00880304035355 | K020381 | 000 |
| 00880304035348 | K020381 | 000 |
| 00880304035331 | K020381 | 000 |
| 00880304035324 | K020381 | 000 |
| 00880304035317 | K020381 | 000 |
| 00880304035300 | K020381 | 000 |
| 00880304023765 | K020381 | 000 |