The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Modular Radial Head Replacement Device.
| Device ID | K040611 |
| 510k Number | K040611 |
| Device Name: | MODULAR RADIAL HEAD REPLACEMENT DEVICE |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-08 |
| Decision Date | 2004-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304438330 | K040611 | 000 |
| 00880304210370 | K040611 | 000 |
| 00880304210363 | K040611 | 000 |
| 00880304210356 | K040611 | 000 |
| 00880304210349 | K040611 | 000 |
| 00880304210332 | K040611 | 000 |
| 00880304210325 | K040611 | 000 |
| 00880304210318 | K040611 | 000 |
| 00880304210301 | K040611 | 000 |
| 00880304210295 | K040611 | 000 |
| 00880304210288 | K040611 | 000 |
| 00880304210271 | K040611 | 000 |
| 00880304210264 | K040611 | 000 |
| 00880304210257 | K040611 | 000 |
| 00880304210240 | K040611 | 000 |
| 00880304210387 | K040611 | 000 |
| 00880304210394 | K040611 | 000 |
| 00880304438323 | K040611 | 000 |
| 00880304438316 | K040611 | 000 |
| 00880304438309 | K040611 | 000 |
| 00880304438293 | K040611 | 000 |
| 00880304210493 | K040611 | 000 |
| 00880304210486 | K040611 | 000 |
| 00880304210479 | K040611 | 000 |
| 00880304210462 | K040611 | 000 |
| 00880304210455 | K040611 | 000 |
| 00880304210448 | K040611 | 000 |
| 00880304210431 | K040611 | 000 |
| 00880304210424 | K040611 | 000 |
| 00880304210417 | K040611 | 000 |
| 00880304210400 | K040611 | 000 |
| 00880304210233 | K040611 | 000 |