The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Cmw 1 Gentamicin Bone Cement.
| Device ID | K053002 |
| 510k Number | K053002 |
| Device Name: | DEPUY CMW 1 GENTAMICIN BONE CEMENT |
| Classification | Bone Cement, Antibiotic |
| 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 | MBB |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-10-26 |
| Decision Date | 2005-11-22 |
| Summary: | summary |