The following data is part of a premarket notification filed by Depuy Ace with the FDA for Ace Antegrade Retrograde Humeral Nail System.
| Device ID | K033878 |
| 510k Number | K033878 |
| Device Name: | ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DEPUY ACE 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Rhonda Myer |
| Correspondent | Rhonda Myer DEPUY ACE 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 | 2003-12-15 |
| Decision Date | 2004-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868021763 | K033878 | 000 |
| 00887868021756 | K033878 | 000 |
| 00887868021688 | K033878 | 000 |
| 00887868021671 | K033878 | 000 |
| 00887868471414 | K033878 | 000 |
| 00887868471407 | K033878 | 000 |
| 00887868471339 | K033878 | 000 |
| 00887868471322 | K033878 | 000 |