The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Arthrotek Lactonail.
| Device ID | K040500 |
| 510k Number | K040500 |
| Device Name: | ARTHROTEK LACTONAIL |
| Classification | Pin, Fixation, Smooth |
| Applicant | ARTHROTEK, INC. 56 EAST BELL DR. Warsaw, IN 46582 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel ARTHROTEK, INC. 56 EAST BELL DR. Warsaw, IN 46582 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-26 |
| Decision Date | 2004-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304425057 | K040500 | 000 |
| 00880304424951 | K040500 | 000 |
| 00880304424968 | K040500 | 000 |
| 00880304424975 | K040500 | 000 |
| 00880304424982 | K040500 | 000 |
| 00880304424999 | K040500 | 000 |
| 00880304425002 | K040500 | 000 |
| 00880304425019 | K040500 | 000 |
| 00880304425033 | K040500 | 000 |
| 00880304425040 | K040500 | 000 |
| 00880304424944 | K040500 | 000 |