The following data is part of a premarket notification filed by Depuy Spine,inc with the FDA for Vertebroplastic Radiopaque Bone Cement.
| Device ID | K043406 |
| 510k Number | K043406 |
| Device Name: | VERTEBROPLASTIC RADIOPAQUE BONE CEMENT |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | DEPUY SPINE,INC 325 PARAMONT DRIVE Raynham, MA 02767 |
| Contact | Sharon Starowicz |
| Correspondent | Sharon Starowicz DEPUY SPINE,INC 325 PARAMONT DRIVE Raynham, MA 02767 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-10 |
| Decision Date | 2005-07-15 |
| Summary: | summary |