The following data is part of a premarket notification filed by Depuy Spine, A Johnson & Johnson Company with the FDA for Modification To Vertebroplastic Radiopaque Bone Cement.
| Device ID | K071927 |
| 510k Number | K071927 |
| Device Name: | MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Contact | Sharon Starowicz |
| Correspondent | Sharon Starowicz DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-12 |
| Decision Date | 2007-11-21 |
| Summary: | summary |