The following data is part of a premarket notification filed by Carefusion with the FDA for Avamax Vertebral Balloon Model Vbs1010, Vbs1015, Vbs1020.
| Device ID | K093463 |
| 510k Number | K093463 |
| Device Name: | AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | CAREFUSION 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Sharon Nichols CAREFUSION 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-06 |
| Decision Date | 2010-02-26 |
| Summary: | summary |