The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Smartmix Cemvac Pre-filled With Smartset Hv Bone Cement.
| Device ID | K053445 |
| 510k Number | K053445 |
| Device Name: | SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT |
| Classification | Bone Cement |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Natalie S Heck |
| Correspondent | Natalie S Heck DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | LOD |
| Subsequent Product Code | JDZ |
| Subsequent Product Code | KIH |
| Subsequent Product Code | MBB |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-12 |
| Decision Date | 2006-01-06 |
| Summary: | summary |