The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Smartset Gmv Gentamicin Bone Cement.
| Device ID | K081163 |
| 510k Number | K081163 |
| Device Name: | SMARTSET GMV GENTAMICIN BONE CEMENT |
| Classification | Bone Cement, Antibiotic |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | MBB |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-04-24 |
| Decision Date | 2008-05-14 |
| Summary: | summary |