The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Trochanteric Nail System.
| Device ID | K042325 |
| 510k Number | K042325 |
| Device Name: | TROCHANTERIC NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Steve Kahn |
| Correspondent | Steve Kahn DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-27 |
| Decision Date | 2004-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868064739 | K042325 | 000 |
| 00887868064609 | K042325 | 000 |
| 00887868064593 | K042325 | 000 |
| 00887868064586 | K042325 | 000 |
| 00887868064579 | K042325 | 000 |
| 00887868064562 | K042325 | 000 |
| 00887868064555 | K042325 | 000 |
| 00887868064548 | K042325 | 000 |
| 00887868064531 | K042325 | 000 |
| 00887868064524 | K042325 | 000 |
| 00887868064517 | K042325 | 000 |
| 00887868064616 | K042325 | 000 |
| 00887868064623 | K042325 | 000 |
| 00887868064722 | K042325 | 000 |
| 00887868064715 | K042325 | 000 |
| 00887868064708 | K042325 | 000 |
| 00887868064692 | K042325 | 000 |
| 00887868064685 | K042325 | 000 |
| 00887868064678 | K042325 | 000 |
| 00887868064661 | K042325 | 000 |
| 00887868064654 | K042325 | 000 |
| 00887868064647 | K042325 | 000 |
| 00887868064630 | K042325 | 000 |
| 00887868064500 | K042325 | 000 |