The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for 2.5 Mm Lactosorb Screws.
| Device ID | K981666 |
| 510k Number | K981666 |
| Device Name: | 2.5 MM LACTOSORB SCREWS |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary Verstynen |
| Correspondent | Mary Verstynen BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 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 | 1998-05-11 |
| Decision Date | 1998-11-03 |
| Summary: | summary |