The following data is part of a premarket notification filed by Biomet with the FDA for Modified Distal Radius Plating System.
| Device ID | K133939 |
| 510k Number | K133939 |
| Device Name: | MODIFIED DISTAL RADIUS PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano BIOMET 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304811898 | K133939 | 000 |
| 00887868446191 | K133939 | 000 |
| 00887868446207 | K133939 | 000 |
| 00887868446245 | K133939 | 000 |
| 00887868446313 | K133939 | 000 |
| 00887868446320 | K133939 | 000 |
| 00887868129247 | K133939 | 000 |
| 00887868129544 | K133939 | 000 |
| 00880304811843 | K133939 | 000 |
| 00880304811850 | K133939 | 000 |
| 00880304811867 | K133939 | 000 |
| 00880304811874 | K133939 | 000 |
| 00880304811881 | K133939 | 000 |
| 00887868446115 | K133939 | 000 |