The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Smartset Gmv Endurance Gentamicin Bone Cement.
| Device ID | K033382 |
| 510k Number | K033382 |
| Device Name: | SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT |
| Classification | Bone Cement |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Tiffani D Rogers |
| Correspondent | Tiffani D Rogers DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-10-23 |
| Decision Date | 2004-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20603295174278 | K033382 | 000 |
| 20603295168352 | K033382 | 000 |