The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Avaflex Vertebral Augmentation Needle.
| Device ID | K072133 |
| 510k Number | K072133 |
| Device Name: | AVAFLEX VERTEBRAL AUGMENTATION NEEDLE |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD- MPKB-3B Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Sharon Nichols CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD- MPKB-3B Mcgaw Park, IL 60085 |
| Product Code | NDN |
| Subsequent Product Code | HXG |
| Subsequent Product Code | OAR |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-02 |
| Decision Date | 2007-11-20 |
| Summary: | summary |