The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Ace Aim(r) Titanium Supracondylar Nail.
| Device ID | K974781 |
| 510k Number | K974781 |
| Device Name: | DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Kathleen A Dragovich |
| Correspondent | Kathleen A Dragovich DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 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 | 1997-12-22 |
| Decision Date | 1998-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868005275 | K974781 | 000 |
| 00887868510380 | K974781 | 000 |
| 00887868031342 | K974781 | 000 |
| 00887868031366 | K974781 | 000 |
| 00887868031373 | K974781 | 000 |
| 00887868031380 | K974781 | 000 |
| 00887868031397 | K974781 | 000 |
| 00887868031403 | K974781 | 000 |
| 00887868031410 | K974781 | 000 |
| 00887868031427 | K974781 | 000 |
| 00887868031434 | K974781 | 000 |
| 00887868033865 | K974781 | 000 |
| 00887868033872 | K974781 | 000 |
| 00887868005268 | K974781 | 000 |
| 00887868510373 | K974781 | 000 |