The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Dvr Dorsal Plate, Dvr Lateral Plate, Dvr Ulna Plate.
| Device ID | K140622 |
| 510k Number | K140622 |
| Device Name: | DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano 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 | 2014-03-11 |
| Decision Date | 2014-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868132933 | K140622 | 000 |
| 00887868077104 | K140622 | 000 |
| 00887868077111 | K140622 | 000 |
| 00887868077142 | K140622 | 000 |
| 00887868077159 | K140622 | 000 |
| 00887868077166 | K140622 | 000 |
| 00887868129377 | K140622 | 000 |
| 00887868129384 | K140622 | 000 |
| 00887868129391 | K140622 | 000 |
| 00887868129407 | K140622 | 000 |
| 00887868129414 | K140622 | 000 |
| 00887868129421 | K140622 | 000 |
| 00887868129438 | K140622 | 000 |
| 00887868129445 | K140622 | 000 |
| 00887868129452 | K140622 | 000 |
| 00887868129469 | K140622 | 000 |
| 00887868132926 | K140622 | 000 |
| 00887868446078 | K140622 | 000 |