The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb 5.0 Mm Washer.
| Device ID | K001581 |
| 510k Number | K001581 |
| Device Name: | LACTOSORB 5.0 MM WASHER |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Carol Lauster |
| Correspondent | Carol Lauster BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-22 |
| Decision Date | 2001-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304419834 | K001581 | 000 |