The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Arthrotek Resorbable No-profile Lactosorb L-15 Screw & Washer.
| Device ID | K021832 |
| 510k Number | K021832 |
| Device Name: | ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. 56 EAST BELL DR. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Sara B Shultz |
| Correspondent | Sara B Shultz BIOMET, INC. 56 EAST 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 | 2002-06-04 |
| Decision Date | 2002-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304420786 | K021832 | 000 |
| 00880304420779 | K021832 | 000 |
| 00880304420762 | K021832 | 000 |
| 00880304420755 | K021832 | 000 |
| 00880304420748 | K021832 | 000 |
| 00880304420731 | K021832 | 000 |
| 00880304420724 | K021832 | 000 |