The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Ace Bio Win Tibial Nailing System.
| Device ID | K013430 |
| 510k Number | K013430 |
| Device Name: | ACE BIO WIN TIBIAL NAILING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. 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 | 2001-10-16 |
| Decision Date | 2001-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868019258 | K013430 | 000 |
| 00887868019241 | K013430 | 000 |
| 00887868019234 | K013430 | 000 |
| 00887868019210 | K013430 | 000 |
| 00887868018374 | K013430 | 000 |