The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Ace Versanail.
| Device ID | K023115 |
| 510k Number | K023115 |
| Device Name: | ACE VERSANAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Dina L Weissman, J.d. |
| Correspondent | Dina L Weissman, J.d. 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 | 2002-09-19 |
| Decision Date | 2002-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868033001 | K023115 | 000 |
| 00887868032998 | K023115 | 000 |
| 00887868032981 | K023115 | 000 |
| 00887868032974 | K023115 | 000 |
| 00887868032967 | K023115 | 000 |