The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for 2.5mm Inline Fusion Plate.
| Device ID | K131867 |
| 510k Number | K131867 |
| Device Name: | 2.5MM INLINE FUSION 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 | 2013-06-24 |
| Decision Date | 2013-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868075407 | K131867 | 000 |