The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Tibial L-15 Screw And Washer.
| Device ID | K033233 |
| 510k Number | K033233 |
| Device Name: | LACTOSORB TIBIAL L-15 SCREW AND WASHER |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-06 |
| Decision Date | 2003-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304421189 | K033233 | 000 |
| 00880304421158 | K033233 | 000 |
| 00880304421141 | K033233 | 000 |
| 00880304421134 | K033233 | 000 |
| 00880304421127 | K033233 | 000 |
| 00880304421110 | K033233 | 000 |
| 00880304421103 | K033233 | 000 |