The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Explor Modular Radial Head Replacement Device.
| Device ID | K051385 |
| 510k Number | K051385 |
| Device Name: | EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 EAST BELL DR. 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 | 2005-05-27 |
| Decision Date | 2005-08-05 |
| Summary: | summary |