The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Lactoscrew Screw Anchor.
| Device ID | K033355 |
| 510k Number | K033355 |
| Device Name: | LACTOSCREW SCREW ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET ORTHOPEDICS, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary L Verstynen |
| Correspondent | Mary L Verstynen BIOMET ORTHOPEDICS, INC. 56 EAST BELL DR. P.O. BOX 587 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 | 2003-10-20 |
| Decision Date | 2004-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304453401 | K033355 | 000 |
| 00880304453395 | K033355 | 000 |