The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Plates, Meshes, And Panels/sheets.
| Device ID | K011237 |
| 510k Number | K011237 |
| Device Name: | LACTOSORB PLATES, MESHES, AND PANELS/SHEETS |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-23 |
| Decision Date | 2001-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304563834 | K011237 | 000 |
| 00880304452480 | K011237 | 000 |
| 00880304449954 | K011237 | 000 |
| 00880304445130 | K011237 | 000 |
| 00880304419933 | K011237 | 000 |
| 00880304419902 | K011237 | 000 |
| 00880304002692 | K011237 | 000 |