The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Trochanteric Nail.
| Device ID | K010780 |
| 510k Number | K010780 |
| Device Name: | TROCHANTERIC NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-15 |
| Decision Date | 2001-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868064494 | K010780 | 000 |
| 00887868064340 | K010780 | 000 |
| 00887868064333 | K010780 | 000 |
| 00887868064326 | K010780 | 000 |
| 00887868064319 | K010780 | 000 |
| 00887868064302 | K010780 | 000 |
| 00887868064296 | K010780 | 000 |
| 00887868064258 | K010780 | 000 |
| 00887868064241 | K010780 | 000 |
| 00887868064234 | K010780 | 000 |
| 00887868064227 | K010780 | 000 |
| 00887868064210 | K010780 | 000 |
| 00887868064357 | K010780 | 000 |
| 00887868064364 | K010780 | 000 |
| 00887868064371 | K010780 | 000 |
| 00887868064487 | K010780 | 000 |
| 00887868064470 | K010780 | 000 |
| 00887868064463 | K010780 | 000 |
| 00887868064456 | K010780 | 000 |
| 00887868064449 | K010780 | 000 |
| 00887868064432 | K010780 | 000 |
| 00887868064425 | K010780 | 000 |
| 00887868064418 | K010780 | 000 |
| 00887868064401 | K010780 | 000 |
| 00887868064395 | K010780 | 000 |
| 00887868064388 | K010780 | 000 |
| 00887868064203 | K010780 | 000 |