The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lapidus Plate, 3.5mm Inline Fusion Plate, 3.5mm Mtp Plate (left And Right).
| Device ID | K131670 |
| 510k Number | K131670 |
| Device Name: | LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano BIOMET, INC. 56 EAST BELL DR. P.O. 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 | 2013-06-07 |
| Decision Date | 2013-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868075599 | K131670 | 000 |
| 00887868075292 | K131670 | 000 |
| 00887868075285 | K131670 | 000 |
| 00887868075278 | K131670 | 000 |
| 00887868075261 | K131670 | 000 |
| 00887868075254 | K131670 | 000 |
| 00887868075247 | K131670 | 000 |
| 00887868551345 | K131670 | 000 |
| 00887868551338 | K131670 | 000 |
| 00887868551314 | K131670 | 000 |
| 00887868551246 | K131670 | 000 |
| 00887868075308 | K131670 | 000 |
| 00887868075315 | K131670 | 000 |
| 00887868075322 | K131670 | 000 |
| 00887868075582 | K131670 | 000 |
| 00887868075575 | K131670 | 000 |
| 00887868075568 | K131670 | 000 |
| 00887868075445 | K131670 | 000 |
| 00887868075438 | K131670 | 000 |
| 00887868075421 | K131670 | 000 |
| 00887868075414 | K131670 | 000 |
| 00887868075391 | K131670 | 000 |
| 00887868075353 | K131670 | 000 |
| 00887868075339 | K131670 | 000 |
| 00887868551222 | K131670 | 000 |