The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Ace Nancy Nail.
| Device ID | K032687 |
| 510k Number | K032687 |
| Device Name: | ACE NANCY NAIL |
| Classification | Pin, Fixation, Smooth |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Rhonda Myer |
| Correspondent | Rhonda Myer DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-29 |
| Decision Date | 2003-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868032899 | K032687 | 000 |
| 00887868032882 | K032687 | 000 |
| 00887868032875 | K032687 | 000 |
| 00887868032868 | K032687 | 000 |
| 00887868032851 | K032687 | 000 |
| 00887868032844 | K032687 | 000 |