The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Push Screw.
| Device ID | K002423 |
| 510k Number | K002423 |
| Device Name: | LACTOSORB PUSH SCREW |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Tracy Bickel |
| Correspondent | Tracy Bickel BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-08 |
| Decision Date | 2000-10-20 |