The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Smartmix Pre-filled Mixing System.
| Device ID | K042591 |
| 510k Number | K042591 |
| Device Name: | SMARTMIX PRE-FILLED MIXING SYSTEM |
| Classification | Dispenser, Cement |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Tiffani Rogers |
| Correspondent | Tiffani Rogers DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KIH |
| Subsequent Product Code | JDZ |
| Subsequent Product Code | LOD |
| Subsequent Product Code | MBB |
| CFR Regulation Number | 888.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-09-23 |
| Decision Date | 2004-10-22 |
| Summary: | summary |