The following data is part of a premarket notification filed by Carefusion with the FDA for Avamax Vertebral Balloon System, 8g, Avamax Vertebral Balloon System, 10g, Avamax Vertebral Balloon System, 11g.
| Device ID | K131820 |
| 510k Number | K131820 |
| Device Name: | AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G |
| Classification | Arthroscope |
| Applicant | CAREFUSION 75 NORTH FAIRWAY DRIVE Vernon Hills, IL 60061 |
| Contact | Joy Greidanus |
| Correspondent | Joy Greidanus CAREFUSION 75 NORTH FAIRWAY DRIVE Vernon Hills, IL 60061 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-20 |
| Decision Date | 2013-10-04 |
| Summary: | summary |