The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Explor Radial Head Plating System.
| Device ID | K110201 |
| 510k Number | K110201 |
| Device Name: | EXPLOR RADIAL HEAD PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-24 |
| Decision Date | 2011-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304677050 | K110201 | 000 |
| 00880304648814 | K110201 | 000 |
| 00880304648807 | K110201 | 000 |
| 00880304648791 | K110201 | 000 |
| 00880304648647 | K110201 | 000 |
| 00880304648630 | K110201 | 000 |
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| 00880304648616 | K110201 | 000 |
| 00880304648609 | K110201 | 000 |
| 00880304648593 | K110201 | 000 |
| 00880304648586 | K110201 | 000 |
| 00880304648579 | K110201 | 000 |
| 00880304648562 | K110201 | 000 |
| 00880304648555 | K110201 | 000 |
| 00880304648548 | K110201 | 000 |
| 00880304648531 | K110201 | 000 |
| 30880304648679 | K110201 | 000 |
| 00887868512117 | K110201 | 000 |
| 00880304648821 | K110201 | 000 |
| 00880304648838 | K110201 | 000 |
| 00880304649002 | K110201 | 000 |
| 00880304648999 | K110201 | 000 |
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| 00880304648975 | K110201 | 000 |
| 00880304648968 | K110201 | 000 |
| 00880304648951 | K110201 | 000 |
| 00880304648944 | K110201 | 000 |
| 00880304648937 | K110201 | 000 |
| 00880304648920 | K110201 | 000 |
| 00880304648913 | K110201 | 000 |
| 00880304648906 | K110201 | 000 |
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| 00880304648876 | K110201 | 000 |
| 00880304648869 | K110201 | 000 |
| 00880304648852 | K110201 | 000 |
| 00880304648845 | K110201 | 000 |
| 00887868539701 | K110201 | 000 |